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Relative Bioavailability Study With BMS-955176

Primary Purpose

Infection, Human Immunodeficiency Virus

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

BMS-955176

About this trial

This is an interventional other trial for Infection, Human Immunodeficiency Virus

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examinations, vital sign measurements, 12-lead electrocardiogram (ECG) measurements and clinical laboratory test results
Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive. BMI = Weight (kg) / [height (m)]2
Men and women, ages 18 to 50 years, inclusive
Women must not be of childbearing potential, must not be breastfeeding

Exclusion Criteria:

Any significant acute or chronic medical illness
History of cardiac disease or clinically significant cardiac arrhythmias
Current or recent (within 3 months of study drug administration) gastrointestinal disease
Any major surgery within 4 weeks of study drug administration
Any gastrointestinal surgery (including cholecystectomy) that could impact upon the absorption of study drug

Sites / Locations

GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Arm Label

Cohort 1 Arm ABDC: BMS-955176 (Treatment A, B, D and C)

Cohort 1 Arm BCDA: BMS-955176 (Treatment B, C, D and A)

Cohort 1 Arm DABC: BMS-955176 (Treatment D, A, B and C)

Cohort 1 Arm CDAB: BMS-955176 (Treatment C, D, A and B)

Cohort 2 Arm EFGH: BMS-955176 (Treatment E, F, G and H)

Cohort 2 Arm FGHE: BMS-955176 (Treatment F, G, H and E)

Cohort 2 Arm HEFG: BMS-955176 (Treatment H, E, F and G)

Cohort 2 Arm GHEF: BMS-955176 (Treatment G, H, E and F)

Arm Description

BMS-955176 single dose by mouth as specified

Outcomes

Primary Outcome Measures

Maximum observed plasma concentration (Cmax) of BMS-955176

Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-955176

Area under the plasma concentration-time curve from time zero to 72 hours post-dose [AUC(0-72)] of BMS-955176

Secondary Outcome Measures

Time of maximum observed plasma concentration (Tmax) of BMS-955176

Terminal plasma half-life (T-HALF) of BMS-955176

Apparent total body clearance (CLT/F) of BMS-955176

Safety and tolerability based on incidence of adverse events (AEs), serious AEs, AEs leading to discontinuation and deaths, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs and physical examinations

Full Information

NCT ID

NCT02095886

First Posted

March 21, 2014

Last Updated

September 7, 2017

Sponsor

ViiV Healthcare

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT02095886

Brief Title

Relative Bioavailability Study With BMS-955176

Official Title

Assessment of BMS-955176 Bioavailability From a Micronized Crystalline Tablet Relative to a Spray-Dried Dispersion Suspension and Assessment of Additional Experimental Formulations Relative to the Micronized Crystalline Tablet in Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

March 25, 2014 (Actual)

Primary Completion Date

July 7, 2014 (Actual)

Study Completion Date

July 7, 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 select the best dose level (amount of drug given) and best formulation of the study drug (BMS-955176) to develop further.

Detailed Description

Primary Purpose: Other: This study will assess the bioavailability of BMS-955176 from a micronized crystalline (MC) tablet relative to a spray-dried dispersion (SDD) suspension. Assessment of additional experimental formulations relative to the micronized crystalline tablet will also be performed

6. Conditions and Keywords

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

Infection, Human Immunodeficiency Virus

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

47 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1 Arm ABDC: BMS-955176 (Treatment A, B, D and C)

Arm Type

Experimental

Arm Description

BMS-955176 single dose by mouth as specified

Arm Title

Cohort 1 Arm BCDA: BMS-955176 (Treatment B, C, D and A)

Arm Type

Experimental

Arm Description

BMS-955176 single dose by mouth as specified

Arm Title

Cohort 1 Arm DABC: BMS-955176 (Treatment D, A, B and C)

Arm Type

Experimental

Arm Description

BMS-955176 single dose by mouth as specified

Arm Title

Cohort 1 Arm CDAB: BMS-955176 (Treatment C, D, A and B)

Arm Type

Experimental

Arm Description

BMS-955176 single dose by mouth as specified

Arm Title

Cohort 2 Arm EFGH: BMS-955176 (Treatment E, F, G and H)

Arm Type

Experimental

Arm Description

BMS-955176 single dose by mouth as specified

Arm Title

Cohort 2 Arm FGHE: BMS-955176 (Treatment F, G, H and E)

Arm Type

Experimental

Arm Description

BMS-955176 single dose by mouth as specified

Arm Title

Cohort 2 Arm HEFG: BMS-955176 (Treatment H, E, F and G)

Arm Type

Experimental

Arm Description

BMS-955176 single dose by mouth as specified

Arm Title

Cohort 2 Arm GHEF: BMS-955176 (Treatment G, H, E and F)

Arm Type

Experimental

Arm Description

BMS-955176 single dose by mouth as specified

Intervention Type

Drug

Intervention Name(s)

BMS-955176

Intervention Description

BMS-955176

Primary Outcome Measure Information:

Title

Maximum observed plasma concentration (Cmax) of BMS-955176

Time Frame

Days 1-4 of Periods 1, 2, 3 and 4

Title

Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-955176

Time Frame

Days 1-4 of Periods 1, 2, 3 and 4

Title

Area under the plasma concentration-time curve from time zero to 72 hours post-dose [AUC(0-72)] of BMS-955176

Time Frame

Days 1-4 of Periods 1, 2, 3 and 4

Secondary Outcome Measure Information:

Title

Time of maximum observed plasma concentration (Tmax) of BMS-955176

Time Frame

Days 1-4 of Periods 1, 2, 3 and 4

Title

Terminal plasma half-life (T-HALF) of BMS-955176

Time Frame

Days 1-4 of Periods 1, 2, 3 and 4

Title

Apparent total body clearance (CLT/F) of BMS-955176

Time Frame

Days 1-4 of Periods 1, 2, 3 and 4

Title

Time Frame

Up to Period 4/Day 4 (discharge)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examinations, vital sign measurements, 12-lead electrocardiogram (ECG) measurements and clinical laboratory test results Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive. BMI = Weight (kg) / [height (m)]2 Men and women, ages 18 to 50 years, inclusive Women must not be of childbearing potential, must not be breastfeeding Exclusion Criteria: Any significant acute or chronic medical illness History of cardiac disease or clinically significant cardiac arrhythmias Current or recent (within 3 months of study drug administration) gastrointestinal disease Any major surgery within 4 weeks of study drug administration Any gastrointestinal surgery (including cholecystectomy) that could impact upon the absorption of study drug

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

ViiV Healthcare

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Nottingham

ZIP/Postal Code

NG11 6JS

Country

United Kingdom

12. IPD Sharing Statement

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Relative Bioavailability Study With BMS-955176

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