Safety and Pharmacokinetics of Bevirimat (PA-457), a Novel Inhibitor of Human Immunodeficiency Virus Maturation, in Healthy Volunteers
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| Published in | Antimicrobial Agents and Chemotherapy Vol. 51; no. 9; pp. 3063 - 3066 |
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| AbstractList | Bevirimat (BVM; formerly known as PA-457) is a novel inhibitor of human immunodeficiency virus (HIV) maturation that is being developed for the treatment of HIV infection. The pharmacokinetics of this agent in healthy male volunteers were studied in a randomized, double-blind study in which the participants received single oral doses of placebo (n = 8) or escalating doses of BVM at 25, 50, 100, or 250 mg (n = 6 per dose); escalation was performed only after the pharmacokinetics and safety of the preceding dose had been evaluated. Plasma was collected over 480 h after dosing and urine was collected over 48 h after dosing for determination of the values of pharmacokinetic parameters. BVM was well absorbed after oral administration, with peak plasma concentrations being achieved 1 to 3 h after dosing. The half-life was 60 to 80 h. The exposure assessed by determination of the peak concentration and the area under the concentration-time curve was dose proportional. Single oral doses of BVM were well tolerated: there were no dose-limiting toxicities, and no serious adverse events were reported. These findings suggest that that BVM offers a favorable pharmacokinetic profile, with predictable pharmacokinetics following the oral administration of single doses. The long half-life of BVM may facilitate once-daily dosing. Bevirimat (BVM; formerly known as PA-457) is a novel inhibitor of human immunodeficiency virus (HIV) maturation that is being developed for the treatment of HIV infection. The pharmacokinetics of this agent in healthy male volunteers were studied in a randomized, double-blind study in which the participants received single oral doses of placebo ( n = 8) or escalating doses of BVM at 25, 50, 100, or 250 mg ( n = 6 per dose); escalation was performed only after the pharmacokinetics and safety of the preceding dose had been evaluated. Plasma was collected over 480 h after dosing and urine was collected over 48 h after dosing for determination of the values of pharmacokinetic parameters. BVM was well absorbed after oral administration, with peak plasma concentrations being achieved 1 to 3 h after dosing. The half-life was 60 to 80 h. The exposure assessed by determination of the peak concentration and the area under the concentration-time curve was dose proportional. Single oral doses of BVM were well tolerated: there were no dose-limiting toxicities, and no serious adverse events were reported. These findings suggest that that BVM offers a favorable pharmacokinetic profile, with predictable pharmacokinetics following the oral administration of single doses. The long half-life of BVM may facilitate once-daily dosing. Classifications Services AAC Citing Articles Google Scholar PubMed Related Content Social Bookmarking CiteULike Delicious Digg Facebook Google+ Mendeley Reddit StumbleUpon Twitter current issue AAC About AAC Subscribers Authors Reviewers Advertisers Inquiries from the Press Permissions & Commercial Reprints ASM Journals Public Access Policy AAC RSS Feeds 1752 N Street N.W. • Washington DC 20036 202.737.3600 • 202.942.9355 fax • journals@asmusa.org Print ISSN: 0066-4804 Online ISSN: 1098-6596 Copyright © 2014 by the American Society for Microbiology. For an alternate route to AAC .asm.org, visit: AAC Bevirimat (BVM; formerly known as PA-457) is a novel inhibitor of human immunodeficiency virus (HIV) maturation that is being developed for the treatment of HIV infection. The pharmacokinetics of this agent in healthy male volunteers were studied in a randomized, double-blind study in which the participants received single oral doses of placebo (n = 8) or escalating doses of BVM at 25, 50, 100, or 250 mg (n = 6 per dose); escalation was performed only after the pharmacokinetics and safety of the preceding dose had been evaluated. Plasma was collected over 480 h after dosing and urine was collected over 48 h after dosing for determination of the values of pharmacokinetic parameters. BVM was well absorbed after oral administration, with peak plasma concentrations being achieved 1 to 3 h after dosing. The half-life was 60 to 80 h. The exposure assessed by determination of the peak concentration and the area under the concentration-time curve was dose proportional. Single oral doses of BVM were well tolerated: there were no dose-limiting toxicities, and no serious adverse events were reported. These findings suggest that that BVM offers a favorable pharmacokinetic profile, with predictable pharmacokinetics following the oral administration of single doses. The long half-life of BVM may facilitate once-daily dosing.Bevirimat (BVM; formerly known as PA-457) is a novel inhibitor of human immunodeficiency virus (HIV) maturation that is being developed for the treatment of HIV infection. The pharmacokinetics of this agent in healthy male volunteers were studied in a randomized, double-blind study in which the participants received single oral doses of placebo (n = 8) or escalating doses of BVM at 25, 50, 100, or 250 mg (n = 6 per dose); escalation was performed only after the pharmacokinetics and safety of the preceding dose had been evaluated. Plasma was collected over 480 h after dosing and urine was collected over 48 h after dosing for determination of the values of pharmacokinetic parameters. BVM was well absorbed after oral administration, with peak plasma concentrations being achieved 1 to 3 h after dosing. The half-life was 60 to 80 h. The exposure assessed by determination of the peak concentration and the area under the concentration-time curve was dose proportional. Single oral doses of BVM were well tolerated: there were no dose-limiting toxicities, and no serious adverse events were reported. These findings suggest that that BVM offers a favorable pharmacokinetic profile, with predictable pharmacokinetics following the oral administration of single doses. The long half-life of BVM may facilitate once-daily dosing. |
| Author | Charles Ballow John Wilton Gina L. Burgess Judy Doto Philip C. Smith Robert Blum Hal Galbraith David E. Martin |
| AuthorAffiliation | Panacos Pharmaceuticals, Inc., Gaithersburg, Maryland, 1 Buffalo Clinical Research Center, Buffalo, New York, 2 Emprexe Analytical LLC, Buffalo, New York, 3 Quintiles Inc., Kansas City, Missouri, 4 University of North Carolina, Chapel Hill, North Carolina 5 |
| AuthorAffiliation_xml | – name: Panacos Pharmaceuticals, Inc., Gaithersburg, Maryland, 1 Buffalo Clinical Research Center, Buffalo, New York, 2 Emprexe Analytical LLC, Buffalo, New York, 3 Quintiles Inc., Kansas City, Missouri, 4 University of North Carolina, Chapel Hill, North Carolina 5 |
| Author_xml | – sequence: 1 givenname: David E. surname: Martin fullname: Martin, David E. organization: Panacos Pharmaceuticals, Inc., Gaithersburg, Maryland – sequence: 2 givenname: Robert surname: Blum fullname: Blum, Robert organization: Buffalo Clinical Research Center, Buffalo, New York – sequence: 3 givenname: John surname: Wilton fullname: Wilton, John organization: Emprexe Analytical LLC, Buffalo, New York – sequence: 4 givenname: Judy surname: Doto fullname: Doto, Judy organization: Panacos Pharmaceuticals, Inc., Gaithersburg, Maryland – sequence: 5 givenname: Hal surname: Galbraith fullname: Galbraith, Hal organization: Quintiles Inc., Kansas City, Missouri – sequence: 6 givenname: Gina L. surname: Burgess fullname: Burgess, Gina L. organization: Quintiles Inc., Kansas City, Missouri – sequence: 7 givenname: Philip C. surname: Smith fullname: Smith, Philip C. organization: University of North Carolina, Chapel Hill, North Carolina – sequence: 8 givenname: Charles surname: Ballow fullname: Ballow, Charles organization: Buffalo Clinical Research Center, Buffalo, New York |
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| Cites_doi | 10.1001/jama.279.6.450 10.1097/01.aids.0000131310.52526.c7 10.1124/dmd.106.009233 10.1179/acb.2002.041 10.1111/j.1468-1293.2004.00194.x 10.1056/NEJM199803263381301 10.1073/pnas.2234683100 |
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| Keywords | Human Immunopathology Antiretroviral agent Healthy subject Toxicity Retroviridae AIDS Bevirimat Immune deficiency Lentivirus Infection Virus Viral disease Antiviral Inhibitor Human immunodeficiency virus Pharmacokinetics |
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| Notes | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3 Corresponding author. Mailing address: Drug Development, Panacos Pharmaceuticals, 209 Perry Parkway, Suite 7, Gaithersburg, MD 20877. Phone: (240) 631-1395. Fax: (301) 208-8755. E-mail: dmartin@panacos.com |
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| References | e_1_3_2_9_2 e_1_3_2_8_2 e_1_3_2_7_2 (e_1_3_2_12_2) 1985; 13 e_1_3_2_6_2 (e_1_3_2_5_2) 2003; 5 e_1_3_2_10_2 e_1_3_2_11_2 e_1_3_2_4_2 e_1_3_2_3_2 e_1_3_2_13_2 e_1_3_2_2_2 e_1_3_2_14_2 12462795 - Acta Clin Belg. 2002 Jul-Aug;57(4):191-201 16751262 - Drug Metab Dispos. 2006 Sep;34(9):1436-42 9466638 - JAMA. 1998 Feb 11;279(6):450-4 14573704 - Proc Natl Acad Sci U S A. 2003 Nov 11;100(23):13555-60 15199315 - AIDS. 2004 Jul 2;18(10):1393-401 12755128 - Nat Rev Drug Discov. 2003 May;2(5):345-6 2858367 - Drug Metab Dispos. 1985 Jan-Feb;13(1):110-2 9516219 - N Engl J Med. 1998 Mar 26;338(13):853-60 15012649 - HIV Med. 2004 Mar;5(2):99-104 |
| References_xml | – ident: e_1_3_2_3_2 doi: 10.1001/jama.279.6.450 – volume: 5 start-page: 345 year: 2003 ident: e_1_3_2_5_2 publication-title: Nat. Rev. Drug Discovery – ident: e_1_3_2_8_2 – ident: e_1_3_2_11_2 doi: 10.1097/01.aids.0000131310.52526.c7 – ident: e_1_3_2_14_2 doi: 10.1124/dmd.106.009233 – volume: 13 start-page: 110 year: 1985 ident: e_1_3_2_12_2 publication-title: Drug Metab. Dispos. – ident: e_1_3_2_2_2 doi: 10.1179/acb.2002.041 – ident: e_1_3_2_9_2 doi: 10.1111/j.1468-1293.2004.00194.x – ident: e_1_3_2_10_2 doi: 10.1056/NEJM199803263381301 – ident: e_1_3_2_4_2 – ident: e_1_3_2_7_2 – ident: e_1_3_2_6_2 doi: 10.1073/pnas.2234683100 – ident: e_1_3_2_13_2 – reference: 9516219 - N Engl J Med. 1998 Mar 26;338(13):853-60 – reference: 12462795 - Acta Clin Belg. 2002 Jul-Aug;57(4):191-201 – reference: 12755128 - Nat Rev Drug Discov. 2003 May;2(5):345-6 – reference: 9466638 - JAMA. 1998 Feb 11;279(6):450-4 – reference: 15199315 - AIDS. 2004 Jul 2;18(10):1393-401 – reference: 2858367 - Drug Metab Dispos. 1985 Jan-Feb;13(1):110-2 – reference: 15012649 - HIV Med. 2004 Mar;5(2):99-104 – reference: 14573704 - Proc Natl Acad Sci U S A. 2003 Nov 11;100(23):13555-60 – reference: 16751262 - Drug Metab Dispos. 2006 Sep;34(9):1436-42 |
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| SubjectTerms | Adolescent Adult Anti-HIV Agents Anti-HIV Agents - administration & dosage Anti-HIV Agents - adverse effects Anti-HIV Agents - pharmacokinetics Antibiotics. Antiinfectious agents. Antiparasitic agents Area Under Curve Biological and medical sciences Dose-Response Relationship, Drug Double-Blind Method Human immunodeficiency virus Human viral diseases Humans Immunodeficiencies Immunodeficiencies. Immunoglobulinopathies Immunopathology Infectious diseases Male Medical sciences Middle Aged Pharmacology Pharmacology. Drug treatments Succinates Succinates - administration & dosage Succinates - adverse effects Succinates - pharmacokinetics Triterpenes Triterpenes - administration & dosage Triterpenes - adverse effects Triterpenes - pharmacokinetics Viral diseases Viral diseases of the lymphoid tissue and the blood. Aids |
| Title | Safety and Pharmacokinetics of Bevirimat (PA-457), a Novel Inhibitor of Human Immunodeficiency Virus Maturation, in Healthy Volunteers |
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