Food Effect Study With BMS-955176

• Sponsor: ViiV Healthcare (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02273947
• Collaborator: GlaxoSmithKline (Industry)
• Enrollment: 12
• Location: 1
• Arms: 21
• Actual Duration (Months): 21.7
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Infection, Human Immunodeficiency Virus	Drug: BMS-955176	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Actual Study Start Date: Oct 23, 2014
• Actual Primary Completion Date: Aug 15, 2016
• Actual Study Completion Date: Aug 15, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 (ABDC): BMS-955176 BMS-955176 single dose by mouth for each treatment as specified	Drug: BMS-955176; Single dose by mouth for each treatment specified
Experimental: Arm 2 (BCAD): BMS-955176 BMS-955176 single dose by mouth for each treatment as specified	Drug: BMS-955176; Single dose by mouth for each treatment specified
Experimental: Arm 3 (CDBA): BMS-955176 BMS-955176 single dose by mouth for each treatment as specified	Drug: BMS-955176; Single dose by mouth for each treatment specified
Experimental: Arm 4 (DACB): BMS-955176 BMS-955176 single dose by mouth for each treatment as specified	Drug: BMS-955176; Single dose by mouth for each treatment specified
Experimental: Arm 5 (EFHG): BMS-955176 BMS-955176 single dose by mouth for each treatment as specified	Drug: BMS-955176; Single dose by mouth for each treatment specified
Experimental: Arm 6 (FGEH): BMS-955176 BMS-955176 single dose by mouth for each treatment as specified	Drug: BMS-955176; Single dose by mouth for each treatment specified
Experimental: Arm 7 (GHFE): BMS-955176 BMS-955176 single dose by mouth for each treatment as specified	Drug: BMS-955176; Single dose by mouth for each treatment specified
Experimental: Arm 8 (HEGF): BMS-955176 BMS-955176 single dose by mouth for each treatment as specified	Drug: BMS-955176; Single dose by mouth for each treatment specified
Experimental: Arm 9 (IJK): BMS-955176 BMS-955176 single dose by mouth for each treatment specified	Drug: BMS-955176; Single dose by mouth for each treatment specified
Experimental: Arm 10 (JKI): BMS-955176 BMS-955176 single dose by mouth for each treatment specified	Drug: BMS-955176; Single dose by mouth for each treatment specified
Experimental: Arm 11 (KIJ): BMS-955176 BMS-955176 single dose by mouth for each treatment specified	Drug: BMS-955176; Single dose by mouth for each treatment specified
Experimental: Arm 12 (IKJ): BMS-955176 BMS-955176 single dose by mouth for each treatment specified	Drug: BMS-955176; Single dose by mouth for each treatment specified
Experimental: Arm 13 (JIK): BMS-955176 BMS-955176 single dose by mouth for each treatment specified	Drug: BMS-955176; Single dose by mouth for each treatment specified
Experimental: Arm 14 (KJI): BMS-955176 BMS-955176 single dose by mouth for each treatment specified	Drug: BMS-955176; Single dose by mouth for each treatment specified
Experimental: Arm 15 (LMN): BMS-955176 BMS-955176 single dose by mouth for each treatment specified	Drug: BMS-955176; Single dose by mouth for each treatment specified
Experimental: Arm 16 (OPQ): BMS-955176 BMS-955176 single dose by mouth for each treatment specified	Drug: BMS-955176; Single dose by mouth for each treatment specified
Experimental: Arm 17 (PQO): BMS-955176 BMS-955176 single dose by mouth for each treatment specified	Drug: BMS-955176; Single dose by mouth for each treatment specified
Experimental: Arm 18 (QOP): BMS-955176 BMS-955176 single dose by mouth for each treatment specified	Drug: BMS-955176; Single dose by mouth for each treatment specified
Experimental: Arm 19 (OQP): BMS-955176 BMS-955176 single dose by mouth for each treatment specified	Drug: BMS-955176; Single dose by mouth for each treatment specified
Experimental: Arm 20 (POQ): BMS-955176 BMS-955176 single dose by mouth for each treatment specified	Drug: BMS-955176; Single dose by mouth for each treatment specified
Experimental: Arm 21 (QPO): BMS-955176 BMS-955176 single dose by mouth for each treatment specified	Drug: BMS-955176; Single dose by mouth for each treatment specified

Outcome Measures

Primary Outcome Measures

1. Maximum observed plasma concentration (Cmax) for BMS-955176 [Up to Day 4 of Period 4]

2. Area under the plasma concentration-time curve from time zero to 72 hours post-dose [AUC(0-72)] for BMS-955176 [Up to Day 4 of Period 4]

3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] for BMS-955176 [Up to Day 4 of Period 4]

4. Plasma concentration at 24 hours post-dose (C24) for BMS-955176 [Up to Day 4 of Period 4]

Secondary Outcome Measures

1. Safety and tolerability [Up to 30 days post discontinuation of dosing]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Ruddington Fields	Nottinghamshire	United Kingdom	NG11 6JS

Sponsors and Collaborators

• ViiV Healthcare
• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, ViiV Healthcare

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ViiV Healthcare
• ClinicalTrials.gov Identifier: NCT02273947
• Other Study ID Numbers: 206221
• First Posted: Oct 24, 2014
• Last Update Posted: Apr 17, 2017
• Last Verified: Apr 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; BMS-955176

Study Results

No Results Posted as of Apr 17, 2017