Absolute Bioavailability of BMS-626529 After Oral and Intravenous Dosing
Study of the Absolute Bioavailability of BMS-626529 in Healthy Subjects Following Oral Dosing of BMS-663068 and Intravenous Dosing of BMS-626529
2 other identifiers
interventional
36
1 country
1
Brief Summary
A phase I absolute bioavailability study of BMS-626529 following oral and intravenous dosing
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2016
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 5, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 5, 2016
CompletedFirst Submitted
Initial submission to the registry
May 31, 2016
CompletedFirst Posted
Study publicly available on registry
June 20, 2016
CompletedJuly 21, 2017
July 1, 2017
2 months
May 31, 2016
July 18, 2017
Conditions
Outcome Measures
Primary Outcomes (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)
up to 11 days
Secondary Outcomes (2)
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
Study Arms (1)
Oral dose of BMS-663068 + intravenous dose of [13C]BMS 626529
EXPERIMENTALSingle oral dose of BMS-663068 followed by Single intravenous dose of \[13C\]BMS 626529
Interventions
Single oral dose of BMS-663068
Single intravenous dose of \[13C\]BMS 626529
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ViiV Healthcarelead
- GlaxoSmithKlinecollaborator
Study Sites (1)
GSK Investigational Site
Lisburn, BT 28 2 RF, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
ViiV Healthcare
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2016
First Posted
June 20, 2016
Study Start
March 15, 2016
Primary Completion
May 5, 2016
Study Completion
May 5, 2016
Last Updated
July 21, 2017
Record last verified: 2017-07