Food Effect Study With BMS-955176

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Primary Purpose

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

Inclusion Criteria:

Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examinations, vital sign measurements, 12-lead 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 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm 18

Arm 19

Arm 20

Arm 21

Arm Type

Experimental

Arm Label

Arm 1 (ABDC): BMS-955176

Arm 2 (BCAD): BMS-955176

Arm 3 (CDBA): BMS-955176

Arm 4 (DACB): BMS-955176

Arm 5 (EFHG): BMS-955176

Arm 6 (FGEH): BMS-955176

Arm 7 (GHFE): BMS-955176

Arm 8 (HEGF): BMS-955176

Arm 9 (IJK): BMS-955176

Arm 10 (JKI): BMS-955176

Arm 11 (KIJ): BMS-955176

Arm 12 (IKJ): BMS-955176

Arm 13 (JIK): BMS-955176

Arm 14 (KJI): BMS-955176

Arm 15 (LMN): BMS-955176

Arm 16 (OPQ): BMS-955176

Arm 17 (PQO): BMS-955176

Arm 18 (QOP): BMS-955176

Arm 19 (OQP): BMS-955176

Arm 20 (POQ): BMS-955176

Arm 21 (QPO): BMS-955176

Arm Description

BMS-955176 single dose by mouth for each treatment as specified

BMS-955176 single dose by mouth for each treatment specified

Outcomes

Primary Outcome Measures

Maximum observed plasma concentration (Cmax) for BMS-955176

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

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

Plasma concentration at 24 hours post-dose (C24) for BMS-955176

Secondary Outcome Measures

Safety and tolerability

Safety and tolerability measured by incidence of AEs, serious AEs (SAEs), AEs leading to discontinuation and death, marked abnormalities in clinical laboratory tests, viral sign measurements, ECGs, and physical examination Adverse Events (AEs), Electrocardiogram (ECG)

Full Information

NCT ID

NCT02273947

First Posted

October 10, 2014

Last Updated

April 13, 2017

Sponsor

ViiV Healthcare

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT02273947

Brief Title

Food Effect Study With BMS-955176

Official Title

An Open-Label, Randomized, Crossover Adaptive Design Study to Assess the Effect of Food on the Pharmacokinetics of BMS-955176 Administered as a Micronized Crystalline Tablet in Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

October 23, 2014 (Actual)

Primary Completion Date

August 15, 2016 (Actual)

Study Completion Date

August 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ViiV Healthcare

Collaborators

GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief Summary

The purpose of this study is to assess the impact of a light meal, a standard meal, and a high fat meal on the PK of BMS-955176 MC tablet at a dose of 180 mg, relative to fasted conditions.

Detailed Description

Primary Purpose Other: This study will assess the impact of a light meal, a standard meal, and a high fat meal on the pharmacokinetics (PK) of BMS-955176 micronized crystalline (MC) tablet at a dose of 180 mg relative to fasted conditions.

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

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1 (ABDC): BMS-955176

Arm Type

Experimental

Arm Description

BMS-955176 single dose by mouth for each treatment as specified

Arm Title

Arm 2 (BCAD): BMS-955176

Arm Type

Experimental

Arm Description

BMS-955176 single dose by mouth for each treatment as specified

Arm Title

Arm 3 (CDBA): BMS-955176

Arm Type

Experimental

Arm Description

BMS-955176 single dose by mouth for each treatment as specified

Arm Title

Arm 4 (DACB): BMS-955176

Arm Type

Experimental

Arm Description

BMS-955176 single dose by mouth for each treatment as specified

Arm Title

Arm 5 (EFHG): BMS-955176

Arm Type

Experimental

Arm Description

BMS-955176 single dose by mouth for each treatment as specified

Arm Title

Arm 6 (FGEH): BMS-955176

Arm Type

Experimental

Arm Description

BMS-955176 single dose by mouth for each treatment as specified

Arm Title

Arm 7 (GHFE): BMS-955176

Arm Type

Experimental

Arm Description

BMS-955176 single dose by mouth for each treatment as specified

Arm Title

Arm 8 (HEGF): BMS-955176

Arm Type

Experimental

Arm Description

BMS-955176 single dose by mouth for each treatment as specified

Arm Title

Arm 9 (IJK): BMS-955176

Arm Type

Experimental

Arm Description

BMS-955176 single dose by mouth for each treatment specified

Arm Title

Arm 10 (JKI): BMS-955176

Arm Type

Experimental

Arm Description

BMS-955176 single dose by mouth for each treatment specified

Arm Title

Arm 11 (KIJ): BMS-955176

Arm Type

Experimental

Arm Description

BMS-955176 single dose by mouth for each treatment specified

Arm Title

Arm 12 (IKJ): BMS-955176

Arm Type

Experimental

Arm Description

BMS-955176 single dose by mouth for each treatment specified

Arm Title

Arm 13 (JIK): BMS-955176

Arm Type

Experimental

Arm Description

BMS-955176 single dose by mouth for each treatment specified

Arm Title

Arm 14 (KJI): BMS-955176

Arm Type

Experimental

Arm Description

BMS-955176 single dose by mouth for each treatment specified

Arm Title

Arm 15 (LMN): BMS-955176

Arm Type

Experimental

Arm Description

BMS-955176 single dose by mouth for each treatment specified

Arm Title

Arm 16 (OPQ): BMS-955176

Arm Type

Experimental

Arm Description

BMS-955176 single dose by mouth for each treatment specified

Arm Title

Arm 17 (PQO): BMS-955176

Arm Type

Experimental

Arm Description

BMS-955176 single dose by mouth for each treatment specified

Arm Title

Arm 18 (QOP): BMS-955176

Arm Type

Experimental

Arm Description

BMS-955176 single dose by mouth for each treatment specified

Arm Title

Arm 19 (OQP): BMS-955176

Arm Type

Experimental

Arm Description

BMS-955176 single dose by mouth for each treatment specified

Arm Title

Arm 20 (POQ): BMS-955176

Arm Type

Experimental

Arm Description

BMS-955176 single dose by mouth for each treatment specified

Arm Title

Arm 21 (QPO): BMS-955176

Arm Type

Experimental

Arm Description

BMS-955176 single dose by mouth for each treatment specified

Intervention Type

Drug

Intervention Name(s)

BMS-955176

Intervention Description

Single dose by mouth for each treatment specified

Primary Outcome Measure Information:

Title

Maximum observed plasma concentration (Cmax) for BMS-955176

Time Frame

Up to Day 4 of Period 4

Title

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

Time Frame

Up to Day 4 of Period 4

Title

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

Time Frame

Up to Day 4 of Period 4

Title

Plasma concentration at 24 hours post-dose (C24) for BMS-955176

Time Frame

Up to Day 4 of Period 4

Secondary Outcome Measure Information:

Title

Safety and tolerability

Description

Safety and tolerability measured by incidence of AEs, serious AEs (SAEs), AEs leading to discontinuation and death, marked abnormalities in clinical laboratory tests, viral sign measurements, ECGs, and physical examination Adverse Events (AEs), Electrocardiogram (ECG)

Time Frame

Up to 30 days post discontinuation of dosing

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examinations, vital sign measurements, 12-lead 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

Ruddington Fields

State/Province

Nottinghamshire

ZIP/Postal Code

NG11 6JS

Country

United Kingdom

Infection, Human Immunodeficiency Virus

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm 18

Arm 19

Arm 20

Arm 21

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial