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

Phase 1CompletedNCT02206711

ViiV Healthcare21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

HIV Infections

Interventions

BMS-955176DRUG

Single dose of drug on Day 1

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

GSK Investigational Site

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

To asses the PK (AUC, Cmax) of a single oral dose

Serial blood samples for PK parameters determined from plasma concentration versus time

Time frame: 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.

Time frame: Day 1 through Day 13 (predose to 288 hours)

Secondary Outcomes

Safety Assessment

Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests.

Time frame: Day 1 through Day 13

Data from ClinicalTrials.gov

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