Study of the Absorption, Metabolism, and Route of Elimination of a Novel Class of Anti-HIV 1 Drugs (BMS-955176) in Humans.

Phase 1

Completed

• Conditions: HIV Infections
• Interventions: Drug: BMS-955176

• Registration Number: NCT02206711
• Lead Sponsor: ViiV Healthcare

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-30
• Study First Submitted QC: 2014-07-30
• Study First Posted: 2014-08-01
• Study Start: 2014-08-08
• Primary Completion: 2014-09-09
• Study Completion: 2014-09-09
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-13
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 21

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single oral dose of [14C] BMS 955176	BMS-955176	A single 180 mg oral dose of \[14C\] BMS-955176 containing approximately 80 microcurie of total radioactivity.
Nasoduodenal (ND) Tube Cohort	BMS-955176	A 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.

Primary Outcome Measures

Name	Time	Method
To asses the PK (AUC, Cmax) of a single oral dose	Day 1 through Day 13 (predose to 288 hours)	Serial blood samples for PK parameters determined from plasma concentration versus time
To estimate extent of elimination of a single oral dose (% TRA recovery)	Day 1 through Day 13 (predose to 288 hours)	Sample of urinary/fecal/bile will be collected for determining total recovery.

Secondary Outcome Measures

Name	Time	Method
Safety Assessment	Day 1 through Day 13	Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests.

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Madison, Wisconsin, United States