Safety, Tolerability, and Pharmacokinetics of NorUrsodeoxycholic Acid (Shilpa Medicare Limited, India) in Healthy Adults: Results From a Phase I Open‐Label Dose‐Escalation Study
NorUrsodeoxycholic acid (norUDCA) is a side‐chain‐shortened derivative of ursodeoxycholic acid (UDCA) with specific pharmacological properties, including cholehepatic shunting, making it a promising candidate for a range of cholestatic and metabolic liver diseases. This phase I study evaluates the s...
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| Published in | Advances in pharmacological and pharmaceutical sciences Vol. 2025; no. 1; p. 6613969 |
|---|---|
| Main Authors | , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
John Wiley & Sons, Inc
01.01.2025
Wiley |
| Subjects | |
| Online Access | Get full text |
| ISSN | 2633-4682 2633-4690 2633-4690 |
| DOI | 10.1155/adpp/6613969 |
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| Abstract | NorUrsodeoxycholic acid (norUDCA) is a side‐chain‐shortened derivative of ursodeoxycholic acid (UDCA) with specific pharmacological properties, including cholehepatic shunting, making it a promising candidate for a range of cholestatic and metabolic liver diseases. This phase I study evaluates the safety, tolerability, and pharmacokinetics of single ascending doses of norUDCA in healthy adults under fasting conditions. In this open‐label, dose‐escalation study, healthy adults (aged 18–45 years) were enrolled into 3 successive dose escalation cohorts, receiving norUDCA oral tablets of 500 mg ( n = 14), 1000 mg ( n = 14), and 1500 mg ( n = 14) once daily. The primary endpoints were the incidence rate of dose‐limiting toxicities (DLTs), assessment of maximum tolerated dose (MTD) after single dose administration, and an establishment of the recommended phase II dose. Secondary endpoints included pharmacokinetic assessments and evaluation of dose proportionality. Following single‐dose administration of 500 mg, 1000 mg, and 1500 mg, no DLTs were observed, and the MTD was determined to be 1500 mg/day. Maximum plasma concentration ( C max ) and plasma exposure [area under the curve (AUC)] to norUDCA increased dose proportionally from 500 to 1500 mg/day. Median time to achieve maximum plasma concentration ( T max ) for norUDCA at 1500 mg/day cohort (3 h) was comparable to 1000 mg/day cohort (3 h) but lower than 500 mg/day cohort (4 h). The half‐life was longer in 1500 mg/day (16 h) cohort compared to 500 mg/day (15 h) and 1000 mg/day cohorts (14 h). The 90% confidence interval of the slope estimates for C max (22.41, 59.70), AUC 0− t (11.71, 61.14), and AUC 0−inf (10.74, 61.86) did not consistently fall within the predefined acceptable limits (79.69, 120.31) for formal dose proportionality criteria. No serious adverse events or deaths occurred in any cohort. One treatment‐emergent adverse event was observed (an increase in the white blood cell count), which was not related to the study drug. A single dose of norUDCA is safe and well‐tolerated, with favorable plasma pharmacokinetic profiles in healthy subjects. Based on the safety and pharmacokinetic data, the recommended dosage for further clinical trials is 1500 mg/day.
Trial Registration: Clinical Trials Registry‐India: CTRI/2022/11/047561 |
|---|---|
| AbstractList | NorUrsodeoxycholic acid (norUDCA) is a side-chain-shortened derivative of ursodeoxycholic acid (UDCA) with specific pharmacological properties, including cholehepatic shunting, making it a promising candidate for a range of cholestatic and metabolic liver diseases. This phase I study evaluates the safety, tolerability, and pharmacokinetics of single ascending doses of norUDCA in healthy adults under fasting conditions. In this open-label, dose-escalation study, healthy adults (aged 18-45years) were enrolled into 3 successive dose escalation cohorts, receiving norUDCA oral tablets of 500mg (n=14), 1000mg (n=14), and 1500mg (n=14) once daily. The primary endpoints were the incidence rate of dose-limiting toxicities (DLTs), assessment of maximum tolerated dose (MTD) after single dose administration, and an establishment of the recommended phase II dose. Secondary endpoints included pharmacokinetic assessments and evaluation of dose proportionality. Following single-dose administration of 500mg, 1000mg, and 1500mg, no DLTs were observed, and the MTD was determined to be 1500mg/day. Maximum plasma concentration (C[sub.max]) and plasma exposure [area under the curve (AUC)] to norUDCA increased dose proportionally from 500 to 1500mg/day. Median time to achieve maximum plasma concentration (T[sub.max]) for norUDCA at 1500mg/day cohort (3h) was comparable to 1000mg/day cohort (3h) but lower than 500mg/day cohort (4h). The half-life was longer in 1500mg/day (16h) cohort compared to 500mg/day (15h) and 1000mg/day cohorts (14h). The 90% confidence interval of the slope estimates for C[sub.max] (22.41, 59.70), AUC[sub.0-t] (11.71, 61.14), and AUC[sub.0-inf] (10.74, 61.86) did not consistently fall within the predefined acceptable limits (79.69, 120.31) for formal dose proportionality criteria. No serious adverse events or deaths occurred in any cohort. One treatment-emergent adverse event was observed (an increase in the white blood cell count), which was not related to the study drug. A single dose of norUDCA is safe and well-tolerated, with favorable plasma pharmacokinetic profiles in healthy subjects. Based on the safety and pharmacokinetic data, the recommended dosage for further clinical trials is 1500mg/day. NorUrsodeoxycholic acid (norUDCA) is a side-chain-shortened derivative of ursodeoxycholic acid (UDCA) with specific pharmacological properties, including cholehepatic shunting, making it a promising candidate for a range of cholestatic and metabolic liver diseases. This phase I study evaluates the safety, tolerability, and pharmacokinetics of single ascending doses of norUDCA in healthy adults under fasting conditions. In this open-label, dose-escalation study, healthy adults (aged 18–45 years) were enrolled into 3 successive dose escalation cohorts, receiving norUDCA oral tablets of 500 mg (n = 14), 1000 mg (n = 14), and 1500 mg (n = 14) once daily. The primary endpoints were the incidence rate of dose-limiting toxicities (DLTs), assessment of maximum tolerated dose (MTD) after single dose administration, and an establishment of the recommended phase II dose. Secondary endpoints included pharmacokinetic assessments and evaluation of dose proportionality. Following single-dose administration of 500 mg, 1000 mg, and 1500 mg, no DLTs were observed, and the MTD was determined to be 1500 mg/day. Maximum plasma concentration (Cmax) and plasma exposure [area under the curve (AUC)] to norUDCA increased dose proportionally from 500 to 1500 mg/day. Median time to achieve maximum plasma concentration (Tmax) for norUDCA at 1500 mg/day cohort (3 h) was comparable to 1000 mg/day cohort (3 h) but lower than 500 mg/day cohort (4 h). The half-life was longer in 1500 mg/day (16 h) cohort compared to 500 mg/day (15 h) and 1000 mg/day cohorts (14 h). The 90% confidence interval of the slope estimates for Cmax (22.41, 59.70), AUC0−t (11.71, 61.14), and AUC0−inf (10.74, 61.86) did not consistently fall within the predefined acceptable limits (79.69, 120.31) for formal dose proportionality criteria. No serious adverse events or deaths occurred in any cohort. One treatment-emergent adverse event was observed (an increase in the white blood cell count), which was not related to the study drug. A single dose of norUDCA is safe and well-tolerated, with favorable plasma pharmacokinetic profiles in healthy subjects. Based on the safety and pharmacokinetic data, the recommended dosage for further clinical trials is 1500 mg/day.Trial Registration: Clinical Trials Registry-India: CTRI/2022/11/047561 NorUrsodeoxycholic acid (norUDCA) is a side-chain-shortened derivative of ursodeoxycholic acid (UDCA) with specific pharmacological properties, including cholehepatic shunting, making it a promising candidate for a range of cholestatic and metabolic liver diseases. This phase I study evaluates the safety, tolerability, and pharmacokinetics of single ascending doses of norUDCA in healthy adults under fasting conditions. In this open-label, dose-escalation study, healthy adults (aged 18-45 years) were enrolled into 3 successive dose escalation cohorts, receiving norUDCA oral tablets of 500 mg ( = 14), 1000 mg ( = 14), and 1500 mg ( = 14) once daily. The primary endpoints were the incidence rate of dose-limiting toxicities (DLTs), assessment of maximum tolerated dose (MTD) after single dose administration, and an establishment of the recommended phase II dose. Secondary endpoints included pharmacokinetic assessments and evaluation of dose proportionality. Following single-dose administration of 500 mg, 1000 mg, and 1500 mg, no DLTs were observed, and the MTD was determined to be 1500 mg/day. Maximum plasma concentration ( ) and plasma exposure [area under the curve (AUC)] to norUDCA increased dose proportionally from 500 to 1500 mg/day. Median time to achieve maximum plasma concentration ( ) for norUDCA at 1500 mg/day cohort (3 h) was comparable to 1000 mg/day cohort (3 h) but lower than 500 mg/day cohort (4 h). The half-life was longer in 1500 mg/day (16 h) cohort compared to 500 mg/day (15 h) and 1000 mg/day cohorts (14 h). The 90% confidence interval of the slope estimates for (22.41, 59.70), AUC (11.71, 61.14), and AUC (10.74, 61.86) did not consistently fall within the predefined acceptable limits (79.69, 120.31) for formal dose proportionality criteria. No serious adverse events or deaths occurred in any cohort. One treatment-emergent adverse event was observed (an increase in the white blood cell count), which was not related to the study drug. A single dose of norUDCA is safe and well-tolerated, with favorable plasma pharmacokinetic profiles in healthy subjects. Based on the safety and pharmacokinetic data, the recommended dosage for further clinical trials is 1500 mg/day. Clinical Trials Registry-India: CTRI/2022/11/047561. NorUrsodeoxycholic acid (norUDCA) is a side-chain-shortened derivative of ursodeoxycholic acid (UDCA) with specific pharmacological properties, including cholehepatic shunting, making it a promising candidate for a range of cholestatic and metabolic liver diseases. This phase I study evaluates the safety, tolerability, and pharmacokinetics of single ascending doses of norUDCA in healthy adults under fasting conditions. In this open-label, dose-escalation study, healthy adults (aged 18-45years) were enrolled into 3 successive dose escalation cohorts, receiving norUDCA oral tablets of 500mg (n=14), 1000mg (n=14), and 1500mg (n=14) once daily. The primary endpoints were the incidence rate of dose-limiting toxicities (DLTs), assessment of maximum tolerated dose (MTD) after single dose administration, and an establishment of the recommended phase II dose. Secondary endpoints included pharmacokinetic assessments and evaluation of dose proportionality. Following single-dose administration of 500mg, 1000mg, and 1500mg, no DLTs were observed, and the MTD was determined to be 1500mg/day. Maximum plasma concentration (C[sub.max]) and plasma exposure [area under the curve (AUC)] to norUDCA increased dose proportionally from 500 to 1500mg/day. Median time to achieve maximum plasma concentration (T[sub.max]) for norUDCA at 1500mg/day cohort (3h) was comparable to 1000mg/day cohort (3h) but lower than 500mg/day cohort (4h). The half-life was longer in 1500mg/day (16h) cohort compared to 500mg/day (15h) and 1000mg/day cohorts (14h). The 90% confidence interval of the slope estimates for C[sub.max] (22.41, 59.70), AUC[sub.0-t] (11.71, 61.14), and AUC[sub.0-inf] (10.74, 61.86) did not consistently fall within the predefined acceptable limits (79.69, 120.31) for formal dose proportionality criteria. No serious adverse events or deaths occurred in any cohort. One treatment-emergent adverse event was observed (an increase in the white blood cell count), which was not related to the study drug. A single dose of norUDCA is safe and well-tolerated, with favorable plasma pharmacokinetic profiles in healthy subjects. Based on the safety and pharmacokinetic data, the recommended dosage for further clinical trials is 1500mg/day. Trial Registration: Clinical Trials Registry-India: CTRI/2022/11/047561 NorUrsodeoxycholic acid (norUDCA) is a side-chain-shortened derivative of ursodeoxycholic acid (UDCA) with specific pharmacological properties, including cholehepatic shunting, making it a promising candidate for a range of cholestatic and metabolic liver diseases. This phase I study evaluates the safety, tolerability, and pharmacokinetics of single ascending doses of norUDCA in healthy adults under fasting conditions. In this open-label, dose-escalation study, healthy adults (aged 18-45 years) were enrolled into 3 successive dose escalation cohorts, receiving norUDCA oral tablets of 500 mg (n = 14), 1000 mg (n = 14), and 1500 mg (n = 14) once daily. The primary endpoints were the incidence rate of dose-limiting toxicities (DLTs), assessment of maximum tolerated dose (MTD) after single dose administration, and an establishment of the recommended phase II dose. Secondary endpoints included pharmacokinetic assessments and evaluation of dose proportionality. Following single-dose administration of 500 mg, 1000 mg, and 1500 mg, no DLTs were observed, and the MTD was determined to be 1500 mg/day. Maximum plasma concentration (C max) and plasma exposure [area under the curve (AUC)] to norUDCA increased dose proportionally from 500 to 1500 mg/day. Median time to achieve maximum plasma concentration (T max) for norUDCA at 1500 mg/day cohort (3 h) was comparable to 1000 mg/day cohort (3 h) but lower than 500 mg/day cohort (4 h). The half-life was longer in 1500 mg/day (16 h) cohort compared to 500 mg/day (15 h) and 1000 mg/day cohorts (14 h). The 90% confidence interval of the slope estimates for C max (22.41, 59.70), AUC0-t (11.71, 61.14), and AUC0-inf (10.74, 61.86) did not consistently fall within the predefined acceptable limits (79.69, 120.31) for formal dose proportionality criteria. No serious adverse events or deaths occurred in any cohort. One treatment-emergent adverse event was observed (an increase in the white blood cell count), which was not related to the study drug. A single dose of norUDCA is safe and well-tolerated, with favorable plasma pharmacokinetic profiles in healthy subjects. Based on the safety and pharmacokinetic data, the recommended dosage for further clinical trials is 1500 mg/day. Trial Registration: Clinical Trials Registry-India: CTRI/2022/11/047561.NorUrsodeoxycholic acid (norUDCA) is a side-chain-shortened derivative of ursodeoxycholic acid (UDCA) with specific pharmacological properties, including cholehepatic shunting, making it a promising candidate for a range of cholestatic and metabolic liver diseases. This phase I study evaluates the safety, tolerability, and pharmacokinetics of single ascending doses of norUDCA in healthy adults under fasting conditions. In this open-label, dose-escalation study, healthy adults (aged 18-45 years) were enrolled into 3 successive dose escalation cohorts, receiving norUDCA oral tablets of 500 mg (n = 14), 1000 mg (n = 14), and 1500 mg (n = 14) once daily. The primary endpoints were the incidence rate of dose-limiting toxicities (DLTs), assessment of maximum tolerated dose (MTD) after single dose administration, and an establishment of the recommended phase II dose. Secondary endpoints included pharmacokinetic assessments and evaluation of dose proportionality. Following single-dose administration of 500 mg, 1000 mg, and 1500 mg, no DLTs were observed, and the MTD was determined to be 1500 mg/day. Maximum plasma concentration (C max) and plasma exposure [area under the curve (AUC)] to norUDCA increased dose proportionally from 500 to 1500 mg/day. Median time to achieve maximum plasma concentration (T max) for norUDCA at 1500 mg/day cohort (3 h) was comparable to 1000 mg/day cohort (3 h) but lower than 500 mg/day cohort (4 h). The half-life was longer in 1500 mg/day (16 h) cohort compared to 500 mg/day (15 h) and 1000 mg/day cohorts (14 h). The 90% confidence interval of the slope estimates for C max (22.41, 59.70), AUC0-t (11.71, 61.14), and AUC0-inf (10.74, 61.86) did not consistently fall within the predefined acceptable limits (79.69, 120.31) for formal dose proportionality criteria. No serious adverse events or deaths occurred in any cohort. One treatment-emergent adverse event was observed (an increase in the white blood cell count), which was not related to the study drug. A single dose of norUDCA is safe and well-tolerated, with favorable plasma pharmacokinetic profiles in healthy subjects. Based on the safety and pharmacokinetic data, the recommended dosage for further clinical trials is 1500 mg/day. Trial Registration: Clinical Trials Registry-India: CTRI/2022/11/047561. NorUrsodeoxycholic acid (norUDCA) is a side-chain-shortened derivative of ursodeoxycholic acid (UDCA) with specific pharmacological properties, including cholehepatic shunting, making it a promising candidate for a range of cholestatic and metabolic liver diseases. This phase I study evaluates the safety, tolerability, and pharmacokinetics of single ascending doses of norUDCA in healthy adults under fasting conditions. In this open-label, dose-escalation study, healthy adults (aged 18–45 years) were enrolled into 3 successive dose escalation cohorts, receiving norUDCA oral tablets of 500 mg ( n = 14), 1000 mg ( n = 14), and 1500 mg ( n = 14) once daily. The primary endpoints were the incidence rate of dose-limiting toxicities (DLTs), assessment of maximum tolerated dose (MTD) after single dose administration, and an establishment of the recommended phase II dose. Secondary endpoints included pharmacokinetic assessments and evaluation of dose proportionality. Following single-dose administration of 500 mg, 1000 mg, and 1500 mg, no DLTs were observed, and the MTD was determined to be 1500 mg/day. Maximum plasma concentration ( C max ) and plasma exposure [area under the curve (AUC)] to norUDCA increased dose proportionally from 500 to 1500 mg/day. Median time to achieve maximum plasma concentration ( T max ) for norUDCA at 1500 mg/day cohort (3 h) was comparable to 1000 mg/day cohort (3 h) but lower than 500 mg/day cohort (4 h). The half-life was longer in 1500 mg/day (16 h) cohort compared to 500 mg/day (15 h) and 1000 mg/day cohorts (14 h). The 90% confidence interval of the slope estimates for C max (22.41, 59.70), AUC 0− t (11.71, 61.14), and AUC 0−inf (10.74, 61.86) did not consistently fall within the predefined acceptable limits (79.69, 120.31) for formal dose proportionality criteria. No serious adverse events or deaths occurred in any cohort. One treatment-emergent adverse event was observed (an increase in the white blood cell count), which was not related to the study drug. A single dose of norUDCA is safe and well-tolerated, with favorable plasma pharmacokinetic profiles in healthy subjects. Based on the safety and pharmacokinetic data, the recommended dosage for further clinical trials is 1500 mg/day. Trial Registration: Clinical Trials Registry-India: CTRI/2022/11/047561 NorUrsodeoxycholic acid (norUDCA) is a side‐chain‐shortened derivative of ursodeoxycholic acid (UDCA) with specific pharmacological properties, including cholehepatic shunting, making it a promising candidate for a range of cholestatic and metabolic liver diseases. This phase I study evaluates the safety, tolerability, and pharmacokinetics of single ascending doses of norUDCA in healthy adults under fasting conditions. In this open‐label, dose‐escalation study, healthy adults (aged 18–45 years) were enrolled into 3 successive dose escalation cohorts, receiving norUDCA oral tablets of 500 mg ( n = 14), 1000 mg ( n = 14), and 1500 mg ( n = 14) once daily. The primary endpoints were the incidence rate of dose‐limiting toxicities (DLTs), assessment of maximum tolerated dose (MTD) after single dose administration, and an establishment of the recommended phase II dose. Secondary endpoints included pharmacokinetic assessments and evaluation of dose proportionality. Following single‐dose administration of 500 mg, 1000 mg, and 1500 mg, no DLTs were observed, and the MTD was determined to be 1500 mg/day. Maximum plasma concentration ( C max ) and plasma exposure [area under the curve (AUC)] to norUDCA increased dose proportionally from 500 to 1500 mg/day. Median time to achieve maximum plasma concentration ( T max ) for norUDCA at 1500 mg/day cohort (3 h) was comparable to 1000 mg/day cohort (3 h) but lower than 500 mg/day cohort (4 h). The half‐life was longer in 1500 mg/day (16 h) cohort compared to 500 mg/day (15 h) and 1000 mg/day cohorts (14 h). The 90% confidence interval of the slope estimates for C max (22.41, 59.70), AUC 0− t (11.71, 61.14), and AUC 0−inf (10.74, 61.86) did not consistently fall within the predefined acceptable limits (79.69, 120.31) for formal dose proportionality criteria. No serious adverse events or deaths occurred in any cohort. One treatment‐emergent adverse event was observed (an increase in the white blood cell count), which was not related to the study drug. A single dose of norUDCA is safe and well‐tolerated, with favorable plasma pharmacokinetic profiles in healthy subjects. Based on the safety and pharmacokinetic data, the recommended dosage for further clinical trials is 1500 mg/day. Trial Registration: Clinical Trials Registry‐India: CTRI/2022/11/047561 Trial Registration: Clinical Trials Registry-India: CTRI/2022/11/047561 |
| Audience | Academic |
| Author | Panuganti, Veerendra Kumar Mohammad, Javeed Alluri, Chandrasekhar Varma K. S. S. V. V., Sanyasirao Dundigalla, Mamatha Reddy Madala, Pavan Kumar |
| AuthorAffiliation | 3 Bioanalytical Laboratory, Shilpa Medicare Ltd, Hyderabad, Telangana, India 1 Clinical Affairs, Shilpa Medicare Ltd, Hyderabad, Telangana, India 2 Medical Affairs Department, Shilpa Medicare Ltd, Hyderabad, Telangana, India |
| AuthorAffiliation_xml | – name: 2 Medical Affairs Department, Shilpa Medicare Ltd, Hyderabad, Telangana, India – name: 3 Bioanalytical Laboratory, Shilpa Medicare Ltd, Hyderabad, Telangana, India – name: 1 Clinical Affairs, Shilpa Medicare Ltd, Hyderabad, Telangana, India |
| Author_xml | – sequence: 1 givenname: Veerendra Kumar orcidid: 0009-0004-2623-5032 surname: Panuganti fullname: Panuganti, Veerendra Kumar – sequence: 2 givenname: Chandrasekhar Varma orcidid: 0009-0009-5362-1007 surname: Alluri fullname: Alluri, Chandrasekhar Varma – sequence: 3 givenname: Mamatha Reddy orcidid: 0000-0001-8930-7153 surname: Dundigalla fullname: Dundigalla, Mamatha Reddy – sequence: 4 givenname: Javeed orcidid: 0009-0005-8983-2608 surname: Mohammad fullname: Mohammad, Javeed – sequence: 5 givenname: Pavan Kumar orcidid: 0009-0005-3297-3805 surname: Madala fullname: Madala, Pavan Kumar – sequence: 6 givenname: Sanyasirao orcidid: 0009-0007-4125-1200 surname: K. S. S. V. V. fullname: K. S. S. V. V., Sanyasirao |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/40708657$$D View this record in MEDLINE/PubMed |
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| Cites_doi | 10.5487/tr.2013.29.1.053 10.1016/S2468-1253(19)30184-0 10.1002/cpdd.389 10.1159/000454904 10.1002/hep.1840160315 10.1016/j.jhep.2010.08.030 10.1002/hep.23082 10.1159/000371904 10.1002/hep.27074 10.1002/hep.22891 10.1016/j.jhep.2021.06.036 10.1016/j.jhep.2017.05.009 10.1002/hep.20092 10.1053/j.gastro.2005.08.017 |
| ContentType | Journal Article |
| Copyright | Copyright © 2025 Veerendra Kumar Panuganti et al. Advances in Pharmacological and Pharmaceutical Sciences published by John Wiley & Sons Ltd. COPYRIGHT 2025 John Wiley & Sons, Inc. Copyright © 2025 Veerendra Kumar Panuganti et al. Advances in Pharmacological and Pharmaceutical Sciences published by John Wiley & Sons Ltd. This is an open access article under the terms of the Creative Commons Attribution License (the “License”), which permits use, distribution and reproduction in any medium, provided the original work is properly cited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. https://creativecommons.org/licenses/by/4.0 Copyright © 2025 Veerendra Kumar Panuganti et al. Advances in Pharmacological and Pharmaceutical Sciences published by John Wiley & Sons Ltd. 2025 |
| Copyright_xml | – notice: Copyright © 2025 Veerendra Kumar Panuganti et al. Advances in Pharmacological and Pharmaceutical Sciences published by John Wiley & Sons Ltd. – notice: COPYRIGHT 2025 John Wiley & Sons, Inc. – notice: Copyright © 2025 Veerendra Kumar Panuganti et al. Advances in Pharmacological and Pharmaceutical Sciences published by John Wiley & Sons Ltd. This is an open access article under the terms of the Creative Commons Attribution License (the “License”), which permits use, distribution and reproduction in any medium, provided the original work is properly cited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. https://creativecommons.org/licenses/by/4.0 – notice: Copyright © 2025 Veerendra Kumar Panuganti et al. Advances in Pharmacological and Pharmaceutical Sciences published by John Wiley & Sons Ltd. 2025 |
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| Editor | Koteshwara Mudigonda |
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| Keywords | maximum tolerated dose 24-norUrsodeoxycholic acid dose-limiting toxicity healthy subjects safety pharmacokinetic phase I clinical trials |
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| License | Copyright © 2025 Veerendra Kumar Panuganti et al. Advances in Pharmacological and Pharmaceutical Sciences published by John Wiley & Sons Ltd. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. |
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| Snippet | NorUrsodeoxycholic acid (norUDCA) is a side‐chain‐shortened derivative of ursodeoxycholic acid (UDCA) with specific pharmacological properties, including... NorUrsodeoxycholic acid (norUDCA) is a side-chain-shortened derivative of ursodeoxycholic acid (UDCA) with specific pharmacological properties, including... Trial Registration: Clinical Trials Registry-India: CTRI/2022/11/047561 |
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| SubjectTerms | Alcohol Blood cell count Caffeine Cholangitis Clinical trials Drug dosages Gallbladder diseases Hormone replacement therapy Human subjects Liver diseases Medical research Medicare Plasma physics Product development |
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| Title | Safety, Tolerability, and Pharmacokinetics of NorUrsodeoxycholic Acid (Shilpa Medicare Limited, India) in Healthy Adults: Results From a Phase I Open‐Label Dose‐Escalation Study |
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