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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-08

Study Completion Date

2014-09-09

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Single oral dose of [14C] BMS 955176

A single 180 mg oral dose of \[14C\] BMS-955176 containing approximately 80 microcurie of total radioactivity.

Group Type EXPERIMENTAL

BMS-955176

Intervention Type DRUG

Single dose of drug on Day 1

Nasoduodenal (ND) Tube Cohort

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.

Group Type EXPERIMENTAL

BMS-955176

Intervention Type DRUG

Single dose of drug on Day 1

Interventions

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BMS-955176

Single dose of drug on Day 1

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes