---
title: Study of the Absorption, Metabolism, and Route of Elimination of a Novel Class of Anti-HIV 1 Drugs (BMS-955176) in Humans.
nct_id: NCT02206711
overall_status: COMPLETED
phase: PHASE1
sponsor: ViiV Healthcare
study_type: INTERVENTIONAL
primary_condition: HIV Infections
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02206711.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02206711"
ct_last_update_post_date: 2018-04-17
last_seen_at: "2026-05-12T07:21:20.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Study of the Absorption, Metabolism, and Route of Elimination of a Novel Class of Anti-HIV 1 Drugs (BMS-955176) in Humans.

**Official Title:** Pharmacokinetics and Metabolism of [14C] BMS-955176 in Healthy Male Subjects

**NCT ID:** [NCT02206711](https://clinicaltrials.gov/study/NCT02206711)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 21
- **Lead Sponsor:** ViiV Healthcare
- **Collaborators:** GlaxoSmithKline
- **Conditions:** HIV Infections
- **Start Date:** 2014-08-08
- **Completion Date:** 2014-09-09
- **CT.gov Last Update:** 2018-04-17

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 50 Years
- **Sex:** MALE
- **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
```

## Arms

- **Single oral dose of [14C] BMS 955176** (EXPERIMENTAL) — A single 180 mg oral dose of \[14C\] BMS-955176 containing approximately 80 microcurie of total radioactivity.
- **Nasoduodenal (ND) Tube Cohort** (EXPERIMENTAL) — 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.

## Interventions

- **BMS-955176** (DRUG) — Single dose of drug on Day 1

## Primary Outcomes

- **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 Outcomes

- **Safety Assessment** _(time frame: Day 1 through Day 13)_

## Locations (1)

- GSK Investigational Site, Madison, Wisconsin, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.gsk investigational site|madison|wisconsin|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02206711.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02206711*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*