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

HIV Infections Clinical Trial

Official title:

Pharmacokinetics and Metabolism of [14C] BMS-955176 in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02206711
• Other study ID #: 206291
• Secondary ID: AI468-036
• Status: Completed
• Phase: Phase 1
• First received: July 30, 2014
• Last updated: April 13, 2018
• Start date: August 8, 2014
• Est. completion date: September 9, 2014

Study information

• Verified date: April 2018
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 9, 2014
• Est. primary completion date: September 9, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• BMS-955176
Single dose of drug on Day 1

Locations

Country	Name	City	State
United States	GSK Investigational Site	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
ViiV Healthcare	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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