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Absolute Bioavailability of BMS-626529 After Oral and Intravenous Dosing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02805556
Recruitment Status : Completed
First Posted : June 20, 2016
Last Update Posted : July 21, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare

Brief Summary:
A phase I absolute bioavailability study of BMS-626529 following oral and intravenous dosing

Condition or disease Intervention/treatment Phase
Infection, Human Immunodeficiency Virus Drug: BMS-663068 Drug: BMS-626529 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of the Absolute Bioavailability of BMS-626529 in Healthy Subjects Following Oral Dosing of BMS-663068 and Intravenous Dosing of BMS-626529
Actual Study Start Date : March 15, 2016
Actual Primary Completion Date : May 5, 2016
Actual Study Completion Date : May 5, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Oral dose of BMS-663068 + intravenous dose of [13C]BMS 626529
Single oral dose of BMS-663068 followed by Single intravenous dose of [13C]BMS 626529
Drug: BMS-663068
Single oral dose of BMS-663068

Drug: BMS-626529
Single intravenous dose of [13C]BMS 626529




Primary Outcome Measures :
  1. The absolute bioavailability of BMS-626529 after single oral (BMS-663068) and single intravenous dosing ([13C]-BMS-626529) by assessing the primary endpoints AUC(inf) [ Time Frame: up to 11 days ]

Secondary Outcome Measures :
  1. Safety and tolerability of single oral dose of BMS-663068 as determined by medical review of adverse event reports, vital sign measurements, electrocardiograms (ECGs), and results of physical examination and laboratory tests [ Time Frame: up to 31 days ]
  2. Safety and tolerability of single intravenous dose of [13C]-BMS-626529 as determined by medical review of adverse event reports, vital sign measurements, electrocardiograms (ECGs), and results of physical examination and laboratory tests [ Time Frame: up to 31 days ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Generally healthy
  • BMI 18.0-32.0 kg/m2
  • Men sexually active with women of childbearing potential must follow instructions for contraception for the duration of treatment plus 90 days
  • Men must refrain from sperm donation for the length of the study and for 90 days
  • Sign informed consent

Exclusion Criteria:

  • Significant medical illness
  • Tobacco use in the last 12 months
  • Major surgery within 4 weeks of study administration
  • Donation of blood within 4 weeks of study administration
  • Current or recent (within 3 months of study administration) of gastrointestinal disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805556


Locations
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United Kingdom
GSK Investigational Site
Lisburn, United Kingdom, BT 28 2 RF
Sponsors and Collaborators
ViiV Healthcare
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials ViiV Healthcare
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Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT02805556    
Other Study ID Numbers: 206218
AI438-075 ( Other Identifier: Bristol-Myers Squibb )
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Slow Virus Diseases
Fostemsavir
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action