Randomized study of the effect of gadopiclenol, a new gadolinium‐based contrast agent, on the QTc interval in healthy subjects
Aims We investigated the effect of gadopiclenol, a new gadolinium‐based contrast agent, on the QTc interval at clinical and supraclinical dose, considering the relative hyperosmolarity of this product. Methods This was a single centre, randomized, double‐blind, placebo‐ and positive‐controlled, 4‐wa...
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| Published in | British journal of clinical pharmacology Vol. 86; no. 11; pp. 2174 - 2181 |
|---|---|
| Main Authors | , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
England
Wiley
01.11.2020
John Wiley and Sons Inc |
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| Online Access | Get full text |
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| Abstract | Aims
We investigated the effect of gadopiclenol, a new gadolinium‐based contrast agent, on the QTc interval at clinical and supraclinical dose, considering the relative hyperosmolarity of this product.
Methods
This was a single centre, randomized, double‐blind, placebo‐ and positive‐controlled, 4‐way crossover study. Forty‐eight healthy male and female subjects were included to receive single intravenous (i.v.) administrations of gadopiclenol at the clinical dose of 0.1 mmol kg−1, standard for current gadolinium‐based contrast agents, the supraclinical dose of 0.3 mmol kg−1, placebo and a single oral dose of 400 mg moxifloxacin.
Results
The largest time‐matched placebo‐corrected, mean change from‐baseline in QTcF (ΔΔQTcF) was observed 3 hours after administration of 0.1 mmol kg−1 gadopiclenol (2.39 ms, 90% confidence interval [CI]: 0.35, 4.43 ms) and 5 minutes after administration of 0.3 mmol kg−1 (4.81 ms, 90%CI: 2.84, 6.78 ms). The upper limit of the 90% CI was under the threshold of 10 ms, demonstrating no significant effect of gadopiclenol on QTc interval. From 1.5 to 4 hours postdose moxifloxacin, the lower limit of the 90% CI of ΔΔQTcF exceeded 5 ms demonstrating assay sensitivity. Although there was a positive slope, the concentration–response analysis estimated that the values of ΔΔQTcF at the maximal concentration of gadopiclenol at 0.1 and 0.3 mmol kg−1 were 0.41 and 2.23 ms, respectively, with the upper limit of the 90% CI not exceeding 10 ms. No serious or severe adverse events or treatment discontinuations due to adverse events were reported.
Conclusion
This thorough QT/QTc study demonstrated that gadopiclenol did not prolong the QT interval at clinical and supraclinical doses and was well tolerated in healthy volunteers. The positive slope of the QTc prolongation vs concentration relationship suggests that hyperosmolarity could be associated with QTc prolongation. However, the amplitude of this effects is unlikely to be associated with proarrhythmia. |
|---|---|
| AbstractList | Aims
We investigated the effect of gadopiclenol, a new gadolinium‐based contrast agent, on the QTc interval at clinical and supraclinical dose, considering the relative hyperosmolarity of this product.
Methods
This was a single centre, randomized, double‐blind, placebo‐ and positive‐controlled, 4‐way crossover study. Forty‐eight healthy male and female subjects were included to receive single intravenous (i.v.) administrations of gadopiclenol at the clinical dose of 0.1 mmol kg−1, standard for current gadolinium‐based contrast agents, the supraclinical dose of 0.3 mmol kg−1, placebo and a single oral dose of 400 mg moxifloxacin.
Results
The largest time‐matched placebo‐corrected, mean change from‐baseline in QTcF (ΔΔQTcF) was observed 3 hours after administration of 0.1 mmol kg−1 gadopiclenol (2.39 ms, 90% confidence interval [CI]: 0.35, 4.43 ms) and 5 minutes after administration of 0.3 mmol kg−1 (4.81 ms, 90%CI: 2.84, 6.78 ms). The upper limit of the 90% CI was under the threshold of 10 ms, demonstrating no significant effect of gadopiclenol on QTc interval. From 1.5 to 4 hours postdose moxifloxacin, the lower limit of the 90% CI of ΔΔQTcF exceeded 5 ms demonstrating assay sensitivity. Although there was a positive slope, the concentration–response analysis estimated that the values of ΔΔQTcF at the maximal concentration of gadopiclenol at 0.1 and 0.3 mmol kg−1 were 0.41 and 2.23 ms, respectively, with the upper limit of the 90% CI not exceeding 10 ms. No serious or severe adverse events or treatment discontinuations due to adverse events were reported.
Conclusion
This thorough QT/QTc study demonstrated that gadopiclenol did not prolong the QT interval at clinical and supraclinical doses and was well tolerated in healthy volunteers. The positive slope of the QTc prolongation vs concentration relationship suggests that hyperosmolarity could be associated with QTc prolongation. However, the amplitude of this effects is unlikely to be associated with proarrhythmia. Aims: We investigated the effect of gadopiclenol, a new gadolinium-based contrast agent, on the QTc interval at clinical and supraclinical dose, considering the relative hyperosmolarity of this product.Methods: This was a single centre, randomized, double-blind, placebo- and positive-controlled, 4-way crossover study. Forty-eight healthy male and female subjects were included to receive single intravenous (i.v.) administrations of gadopiclenol at the clinical dose of 0.1 mmol kg-1 , standard for current gadolinium-based contrast agents, the supraclinical dose of 0.3 mmol kg-1 , placebo and a single oral dose of 400 mg moxifloxacin.Results: The largest time-matched placebo-corrected, mean change from-baseline in QTcF (ΔΔQTcF) was observed 3 hours after administration of 0.1 mmol kg-1 gadopiclenol (2.39 ms, 90% confidence interval [CI]: 0.35, 4.43 ms) and 5 minutes after administration of 0.3 mmol kg-1 (4.81 ms, 90%CI: 2.84, 6.78 ms). The upper limit of the 90% CI was under the threshold of 10 ms, demonstrating no significant effect of gadopiclenol on QTc interval. From 1.5 to 4 hours postdose moxifloxacin, the lower limit of the 90% CI of ΔΔQTcF exceeded 5 ms demonstrating assay sensitivity. Although there was a positive slope, the concentration-response analysis estimated that the values of ΔΔQTcF at the maximal concentration of gadopiclenol at 0.1 and 0.3 mmol kg-1 were 0.41 and 2.23 ms, respectively, with the upper limit of the 90% CI not exceeding 10 ms. No serious or severe adverse events or treatment discontinuations due to adverse events were reported.Conclusion: This thorough QT/QTc study demonstrated that gadopiclenol did not prolong the QT interval at clinical and supraclinical doses and was well tolerated in healthy volunteers. The positive slope of the QTc prolongation vs concentration relationship suggests that hyperosmolarity could be associated with QTc prolongation. However, the amplitude of this effects is unlikely to be associated with proarrhythmia. We investigated the effect of gadopiclenol, a new gadolinium-based contrast agent, on the QTc interval at clinical and supraclinical dose, considering the relative hyperosmolarity of this product. This was a single centre, randomized, double-blind, placebo- and positive-controlled, 4-way crossover study. Forty-eight healthy male and female subjects were included to receive single intravenous (i.v.) administrations of gadopiclenol at the clinical dose of 0.1 mmol kg , standard for current gadolinium-based contrast agents, the supraclinical dose of 0.3 mmol kg , placebo and a single oral dose of 400 mg moxifloxacin. The largest time-matched placebo-corrected, mean change from-baseline in QTcF (ΔΔQTcF) was observed 3 hours after administration of 0.1 mmol kg gadopiclenol (2.39 ms, 90% confidence interval [CI]: 0.35, 4.43 ms) and 5 minutes after administration of 0.3 mmol kg (4.81 ms, 90%CI: 2.84, 6.78 ms). The upper limit of the 90% CI was under the threshold of 10 ms, demonstrating no significant effect of gadopiclenol on QTc interval. From 1.5 to 4 hours postdose moxifloxacin, the lower limit of the 90% CI of ΔΔQTcF exceeded 5 ms demonstrating assay sensitivity. Although there was a positive slope, the concentration-response analysis estimated that the values of ΔΔQTcF at the maximal concentration of gadopiclenol at 0.1 and 0.3 mmol kg were 0.41 and 2.23 ms, respectively, with the upper limit of the 90% CI not exceeding 10 ms. No serious or severe adverse events or treatment discontinuations due to adverse events were reported. This thorough QT/QTc study demonstrated that gadopiclenol did not prolong the QT interval at clinical and supraclinical doses and was well tolerated in healthy volunteers. The positive slope of the QTc prolongation vs concentration relationship suggests that hyperosmolarity could be associated with QTc prolongation. However, the amplitude of this effects is unlikely to be associated with proarrhythmia. We investigated the effect of gadopiclenol, a new gadolinium-based contrast agent, on the QTc interval at clinical and supraclinical dose, considering the relative hyperosmolarity of this product.AIMSWe investigated the effect of gadopiclenol, a new gadolinium-based contrast agent, on the QTc interval at clinical and supraclinical dose, considering the relative hyperosmolarity of this product.This was a single centre, randomized, double-blind, placebo- and positive-controlled, 4-way crossover study. Forty-eight healthy male and female subjects were included to receive single intravenous (i.v.) administrations of gadopiclenol at the clinical dose of 0.1 mmol kg-1 , standard for current gadolinium-based contrast agents, the supraclinical dose of 0.3 mmol kg-1 , placebo and a single oral dose of 400 mg moxifloxacin.METHODSThis was a single centre, randomized, double-blind, placebo- and positive-controlled, 4-way crossover study. Forty-eight healthy male and female subjects were included to receive single intravenous (i.v.) administrations of gadopiclenol at the clinical dose of 0.1 mmol kg-1 , standard for current gadolinium-based contrast agents, the supraclinical dose of 0.3 mmol kg-1 , placebo and a single oral dose of 400 mg moxifloxacin.The largest time-matched placebo-corrected, mean change from-baseline in QTcF (ΔΔQTcF) was observed 3 hours after administration of 0.1 mmol kg-1 gadopiclenol (2.39 ms, 90% confidence interval [CI]: 0.35, 4.43 ms) and 5 minutes after administration of 0.3 mmol kg-1 (4.81 ms, 90%CI: 2.84, 6.78 ms). The upper limit of the 90% CI was under the threshold of 10 ms, demonstrating no significant effect of gadopiclenol on QTc interval. From 1.5 to 4 hours postdose moxifloxacin, the lower limit of the 90% CI of ΔΔQTcF exceeded 5 ms demonstrating assay sensitivity. Although there was a positive slope, the concentration-response analysis estimated that the values of ΔΔQTcF at the maximal concentration of gadopiclenol at 0.1 and 0.3 mmol kg-1 were 0.41 and 2.23 ms, respectively, with the upper limit of the 90% CI not exceeding 10 ms. No serious or severe adverse events or treatment discontinuations due to adverse events were reported.RESULTSThe largest time-matched placebo-corrected, mean change from-baseline in QTcF (ΔΔQTcF) was observed 3 hours after administration of 0.1 mmol kg-1 gadopiclenol (2.39 ms, 90% confidence interval [CI]: 0.35, 4.43 ms) and 5 minutes after administration of 0.3 mmol kg-1 (4.81 ms, 90%CI: 2.84, 6.78 ms). The upper limit of the 90% CI was under the threshold of 10 ms, demonstrating no significant effect of gadopiclenol on QTc interval. From 1.5 to 4 hours postdose moxifloxacin, the lower limit of the 90% CI of ΔΔQTcF exceeded 5 ms demonstrating assay sensitivity. Although there was a positive slope, the concentration-response analysis estimated that the values of ΔΔQTcF at the maximal concentration of gadopiclenol at 0.1 and 0.3 mmol kg-1 were 0.41 and 2.23 ms, respectively, with the upper limit of the 90% CI not exceeding 10 ms. No serious or severe adverse events or treatment discontinuations due to adverse events were reported.This thorough QT/QTc study demonstrated that gadopiclenol did not prolong the QT interval at clinical and supraclinical doses and was well tolerated in healthy volunteers. The positive slope of the QTc prolongation vs concentration relationship suggests that hyperosmolarity could be associated with QTc prolongation. However, the amplitude of this effects is unlikely to be associated with proarrhythmia.CONCLUSIONThis thorough QT/QTc study demonstrated that gadopiclenol did not prolong the QT interval at clinical and supraclinical doses and was well tolerated in healthy volunteers. The positive slope of the QTc prolongation vs concentration relationship suggests that hyperosmolarity could be associated with QTc prolongation. However, the amplitude of this effects is unlikely to be associated with proarrhythmia. |
| Author | Voiriot, Pascal Desché, Pierre Funck‐Brentano, Christian Felices, Mathieu Le Fur, Nathalie Dubourdieu, Corinne Vanhoutte, Frédéric |
| AuthorAffiliation | 5 Cardiabase Nancy France 3 Guerbet Roissy CDG Cedex France 4 SGS Clinical Pharmacology Unit, ZNA Stuivenberg Antwerp Belgium 1 INSERM, CIC‐1901 and UMRS 1166, Paris, France; AP‐HP, Pitié‐Salpêtrière Hospital, Department of Pharmacology and CIC‐1901, Paris, France; Sorbonne Université Médecine, Paris, France; Institute of Cardiometabolism and Nutrition (ICAN) Paris France 2 Phinc Massy France |
| AuthorAffiliation_xml | – name: 1 INSERM, CIC‐1901 and UMRS 1166, Paris, France; AP‐HP, Pitié‐Salpêtrière Hospital, Department of Pharmacology and CIC‐1901, Paris, France; Sorbonne Université Médecine, Paris, France; Institute of Cardiometabolism and Nutrition (ICAN) Paris France – name: 4 SGS Clinical Pharmacology Unit, ZNA Stuivenberg Antwerp Belgium – name: 5 Cardiabase Nancy France – name: 3 Guerbet Roissy CDG Cedex France – name: 2 Phinc Massy France |
| Author_xml | – sequence: 1 givenname: Christian orcidid: 0000-0003-0406-5189 surname: Funck‐Brentano fullname: Funck‐Brentano, Christian email: christian.funck-brentano@aphp.fr organization: INSERM, CIC‐1901 and UMRS 1166, Paris, France; AP‐HP, Pitié‐Salpêtrière Hospital, Department of Pharmacology and CIC‐1901, Paris, France; Sorbonne Université Médecine, Paris, France; Institute of Cardiometabolism and Nutrition (ICAN) – sequence: 2 givenname: Mathieu surname: Felices fullname: Felices, Mathieu organization: Phinc – sequence: 3 givenname: Nathalie orcidid: 0000-0001-5078-3494 surname: Le Fur fullname: Le Fur, Nathalie organization: Guerbet – sequence: 4 givenname: Corinne surname: Dubourdieu fullname: Dubourdieu, Corinne organization: Guerbet – sequence: 5 givenname: Pierre orcidid: 0000-0002-2389-0697 surname: Desché fullname: Desché, Pierre organization: Guerbet – sequence: 6 givenname: Frédéric surname: Vanhoutte fullname: Vanhoutte, Frédéric organization: SGS Clinical Pharmacology Unit, ZNA Stuivenberg – sequence: 7 givenname: Pascal surname: Voiriot fullname: Voiriot, Pascal organization: Cardiabase |
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| Keywords | QTc interval thorough QT study healthy subjects gadopiclenol osmolarity |
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We investigated the effect of gadopiclenol, a new gadolinium‐based contrast agent, on the QTc interval at clinical and supraclinical dose, considering the... We investigated the effect of gadopiclenol, a new gadolinium-based contrast agent, on the QTc interval at clinical and supraclinical dose, considering the... Aims: We investigated the effect of gadopiclenol, a new gadolinium-based contrast agent, on the QTc interval at clinical and supraclinical dose, considering... |
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| SubjectTerms | gadopiclenol healthy subjects Life Sciences Original osmolarity Pharmaceutical sciences Pharmacology QTc interval thorough QT study |
| Title | Randomized study of the effect of gadopiclenol, a new gadolinium‐based contrast agent, on the QTc interval in healthy subjects |
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