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NCT02805556 Clinical Trial

Absolute Bioavailability of BMS-626529 After Oral and Intravenous Dosing

Infection, Human Immunodeficiency Virus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02805556
Other study ID # 206218
Secondary ID AI438-075
Status Completed
Phase Phase 1
First received May 31, 2016
Last updated July 18, 2017
Start date March 15, 2016
Est. completion date May 5, 2016

Study information
Verified date July 2017
Source ViiV Healthcare
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date May 5, 2016
Est. primary completion date May 5, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• BMS-663068
Single oral dose of BMS-663068
• BMS-626529
Single intravenous dose of [13C]BMS 626529

Locations
Country Name City State
United Kingdom GSK Investigational Site Lisburn

Sponsors (2)
Lead Sponsor Collaborator
ViiV Healthcare GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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) up to 11 days
Secondary 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 up to 31 days
Secondary 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 up to 31 days
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