Study of the Absorption, Metabolism, and Route of Elimination of a Novel Class of Anti-HIV 1 Drugs (BMS-955176) in Humans.
Pharmacokinetics and Metabolism of [14C] BMS-955176 in Healthy Male Subjects
2 other identifiers
interventional
21
1 country
1
Brief Summary
The purpose of this study is to assess the pharmacokinetics (PK), metabolism, routes and extent of elimination, safety and tolerability of a single oral dose of \[14C\] BMS-955176 in healthy male subjects. There is no formal research hypothesis to be statistically tested for this study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 hiv-infections
Started Aug 2014
Shorter than P25 for phase_1 hiv-infections
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
First Submitted
Initial submission to the registry
July 30, 2014
CompletedFirst Posted
Study publicly available on registry
August 1, 2014
CompletedStudy Start
First participant enrolled
August 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 9, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 9, 2014
CompletedApril 17, 2018
April 1, 2018
1 month
July 30, 2014
April 13, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
To asses the PK (AUC, Cmax) of a single oral dose
Serial blood samples for PK parameters determined from plasma concentration versus time
Day 1 through Day 13 (predose to 288 hours)
To estimate extent of elimination of a single oral dose (% TRA recovery)
Sample of urinary/fecal/bile will be collected for determining total recovery.
Day 1 through Day 13 (predose to 288 hours)
Secondary Outcomes (1)
Safety Assessment
Day 1 through Day 13
Study Arms (2)
Single oral dose of [14C] BMS 955176
EXPERIMENTALA single 180 mg oral dose of \[14C\] BMS-955176 containing approximately 80 microcurie of total radioactivity.
Nasoduodenal (ND) Tube Cohort
EXPERIMENTALA single dose of \[14C\] BMS 955176 on Day 1 with ND placement 1 hour post dose to facilitate continuous bile collection though 8 hours post dose.
Interventions
Single dose of drug on Day 1
Eligibility Criteria
You may qualify if:
- Healthy Male subjects
- Ages 18-50 years
- Body weight of at least 110 lbs (50kg)
- BMI of 18 to 32 kg/m\^2
- non-smoking
You may not qualify if:
- Clinically significant diagnostic or therapeutic radiation exposure within the previous 12 months (eg serial X-ray or CAT scans, barium meals).
- gastrointestinal disease including gastrointestinal surgery
- constipation or irregular bowel movements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ViiV Healthcarelead
- GlaxoSmithKlinecollaborator
Study Sites (1)
GSK Investigational Site
Madison, Wisconsin, 53704, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Viiv Clinical Trials
ViiV Healthcare
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2014
First Posted
August 1, 2014
Study Start
August 8, 2014
Primary Completion
September 9, 2014
Study Completion
September 9, 2014
Last Updated
April 17, 2018
Record last verified: 2018-04