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

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

BMS-955176

About this trial

This is an interventional other trial for HIV Infections

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Single oral dose of [14C] BMS 955176

Nasoduodenal (ND) Tube Cohort

Arm Description

A single 180 mg oral dose of [14C] BMS-955176 containing approximately 80 microcurie of total radioactivity.

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.

Outcomes

Primary Outcome Measures

To asses the PK (AUC, Cmax) of a single oral dose

Serial blood samples for PK parameters determined from plasma concentration versus time

To estimate extent of elimination of a single oral dose (% TRA recovery)

Sample of urinary/fecal/bile will be collected for determining total recovery.

Secondary Outcome Measures

Safety Assessment

Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests.

Full Information

NCT ID

NCT02206711

First Posted

July 30, 2014

Last Updated

April 13, 2018

Sponsor

ViiV Healthcare

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT02206711

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

August 8, 2014 (Actual)

Primary Completion Date

September 9, 2014 (Actual)

Study Completion Date

September 9, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ViiV Healthcare

Collaborators

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single oral dose of [14C] BMS 955176

Arm Type

Experimental

Arm Description

A single 180 mg oral dose of [14C] BMS-955176 containing approximately 80 microcurie of total radioactivity.

Arm Title

Nasoduodenal (ND) Tube Cohort

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

BMS-955176

Intervention Description

Single dose of drug on Day 1

Primary Outcome Measure Information:

Title

To asses the PK (AUC, Cmax) of a single oral dose

Description

Serial blood samples for PK parameters determined from plasma concentration versus time

Time Frame

Day 1 through Day 13 (predose to 288 hours)

Title

To estimate extent of elimination of a single oral dose (% TRA recovery)

Description

Sample of urinary/fecal/bile will be collected for determining total recovery.

Time Frame

Day 1 through Day 13 (predose to 288 hours)

Secondary Outcome Measure Information:

Title

Safety Assessment

Description

Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests.

Time Frame

Day 1 through Day 13

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Viiv Clinical Trials

Organizational Affiliation

ViiV Healthcare

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53704

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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