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Clinical Trials

MainTitle

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
Sponsor
Bristol-Myers Squibb


Information provided by (Responsible Party)
Bristol-Myers Squibb
ClinicalTrials.gov Identifier
NCT02206711

First received: July 30, 2014
Last updated: September 11, 2014
Last Verified: September 2014
History of Changes
Purpose

Purpose

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

Drug : BMS-955176
Phase 1

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

Further study details as provided by Bristol-Myers Squibb:

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: 9
Study Start Date: August 2014
Study Completion Date: September 2014
Primary Completion Date: September 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

Eligibility

Eligibility

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

Criteria

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 ClinicalTrials.gov identifier: NCT02206711

Locations

United States, Wisconsin
Covance Clinical Research Unit Inc
Madison, Wisconsin, United States, 53704

Sponsors and Collaborators

Bristol-Myers Squibb
More Information

More Information


Responsible Party: Bristol-Myers Squibb  
ClinicalTrials.gov Identifier: NCT02206711   History of Changes  
Other Study ID Numbers: AI468-036  
Study First Received: July 30, 2014  
Last Updated: September 11, 2014  

ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.