Absolute Bioavailability of BMS-626529 After Oral and Intravenous Dosing

Phase 1

Completed

• Conditions: Infection, Human Immunodeficiency Virus
• Interventions: Drug: BMS-663068; Drug: BMS-626529

• Registration Number: NCT02805556
• Lead Sponsor: ViiV Healthcare

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-15
• Primary Completion: 2016-05-05
• Study Completion: 2016-05-05
• Study First Submitted: 2016-05-31
• Study First Submitted QC: 2016-06-15
• Study First Posted: 2016-06-20
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-18
• Last Update Posted: 2017-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oral dose of BMS-663068 + intravenous dose of [13C]BMS 626529	BMS-663068	Single oral dose of BMS-663068 followed by Single intravenous dose of \[13C\]BMS 626529
Oral dose of BMS-663068 + intravenous dose of [13C]BMS 626529	BMS-626529	Single oral dose of BMS-663068 followed by Single intravenous dose of \[13C\]BMS 626529

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 Lisburn, United Kingdom