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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02206711

Enrollment

Registered

2014-08-01

Start date

2014-08-08

Completion date

2014-09-09

Last updated

2018-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Brief 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.

Interventions

DRUGBMS-955176

Single dose of drug on Day 1

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

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

Design outcomes

Primary

Measure	Time frame	Description
To asses the PK (AUC, Cmax) of a single oral dose	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)	Day 1 through Day 13 (predose to 288 hours)	Sample of urinary/fecal/bile will be collected for determining total recovery.

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026