Clinical Trials


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

This study has been completed
ViiV Healthcare


Information provided by (Responsible Party)
ViiV Healthcare Identifier

First received: July 30, 2014
Last updated: April 13, 2018
Last Verified: April 2018
History of Changes


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.

Condition Intervention Phase
HIV Infections

Drug : BMS-955176
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pharmacokinetics and Metabolism of [14C] BMS-955176 in Healthy Male Subjects

Further study details as provided by ViiV Healthcare:

Primary Outcome Measures

  • To asses the PK (AUC, Cmax) of a single oral dose [ Time Frame: 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) [ Time Frame: Day 1 through Day 13 (predose to 288 hours) ]
    Sample of urinary/fecal/bile will be collected for determining total recovery.
Secondary Outcome Measures:
  • Safety Assessment [ Time Frame: Day 1 through Day 13 ]
    Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests.

Enrollment: 21
Study Start Date: August 8, 2014
Study Completion Date: September 9, 2014
Primary Completion Date: September 9, 2014 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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



Ages Eligible for Study: 18 Years to 50 Years  
Sexes Eligible for Study: Male  
Accepts Healthy Volunteers: Yes  


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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02206711


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

Sponsors and Collaborators

ViiV Healthcare


Study Director: Viiv Clinical Trials ViiV Healthcare
More Information

More Information

Responsible Party: ViiV Healthcare Identifier: NCT02206711   History of Changes  
Other Study ID Numbers: 206291  
Study First Received: July 30, 2014  
Last Updated: April 13, 2018  

Additional relevant MeSH terms:
HIV Infections processed this data on July 16, 2018
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