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

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 Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: BMS-955176

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single oral dose of [14C] BMS 955176; A single 180 mg oral dose of [14C] BMS-955176 containing approximately 80 microcurie of total radioactivity.	Drug: BMS-955176; Single dose of drug on Day 1
Experimental: 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.	Drug: BMS-955176; Single dose of drug on Day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: ViiV Healthcare
• Collaborators: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2014
• Primary Completion (Actual): September 9, 2014
• Study Completion (Actual): September 9, 2014

Study Registration Dates

• First Submitted: July 30, 2014
• First Submitted That Met QC Criteria: July 30, 2014
• First Posted (Estimate): August 1, 2014

Study Record Updates

• Last Update Posted (Actual): April 17, 2018
• Last Update Submitted That Met QC Criteria: April 13, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; BMS-955176
• Other Study ID Numbers: 206291; AI468-036 (Other Identifier: Bristol-Myers Squibb)