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

ViiV Healthcare

Status and phase: Completed; Phase 1

Conditions: HIV Infections

Treatments: Drug: BMS-955176

Study type: Interventional

Funder types: Industry

Identifiers

NCT02206711

AI468-036 (Other Identifier)

206291

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Single oral dose of [14C] BMS 955176

Experimental group

Description:

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

Treatment:

Drug: BMS-955176

Nasoduodenal (ND) Tube Cohort

Experimental group

Description:

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.

Treatment:

Drug: BMS-955176