Relative Bioavailability Study With BMS-955176

• Sponsor: ViiV Healthcare (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02095886
• Collaborator: GlaxoSmithKline (Industry)
• Enrollment: 47
• Location: 1
• Arms: 8
• Actual Duration (Months): 3.4
• Patients Per Site Per Month: 13.8

Study Details

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.

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 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

Study Design

• Study Type: Interventional
• Actual Enrollment: 47 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Actual Study Start Date: Mar 25, 2014
• Actual Primary Completion Date: Jul 7, 2014
• Actual Study Completion Date: Jul 7, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 Arm ABDC: BMS-955176 (Treatment A, B, D and C) BMS-955176 single dose by mouth as specified	Drug: BMS-955176; BMS-955176
Experimental: Cohort 1 Arm BCDA: BMS-955176 (Treatment B, C, D and A) BMS-955176 single dose by mouth as specified	Drug: BMS-955176; BMS-955176
Experimental: Cohort 1 Arm DABC: BMS-955176 (Treatment D, A, B and C) BMS-955176 single dose by mouth as specified	Drug: BMS-955176; BMS-955176
Experimental: Cohort 1 Arm CDAB: BMS-955176 (Treatment C, D, A and B) BMS-955176 single dose by mouth as specified	Drug: BMS-955176; BMS-955176
Experimental: Cohort 2 Arm EFGH: BMS-955176 (Treatment E, F, G and H) BMS-955176 single dose by mouth as specified	Drug: BMS-955176; BMS-955176
Experimental: Cohort 2 Arm FGHE: BMS-955176 (Treatment F, G, H and E) BMS-955176 single dose by mouth as specified	Drug: BMS-955176; BMS-955176
Experimental: Cohort 2 Arm HEFG: BMS-955176 (Treatment H, E, F and G) BMS-955176 single dose by mouth as specified	Drug: BMS-955176; BMS-955176
Experimental: Cohort 2 Arm GHEF: BMS-955176 (Treatment G, H, E and F) BMS-955176 single dose by mouth as specified	Drug: BMS-955176; BMS-955176

Outcome Measures

Primary Outcome Measures

1. Maximum observed plasma concentration (Cmax) of BMS-955176 [Days 1-4 of Periods 1, 2, 3 and 4]

2. Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-955176 [Days 1-4 of Periods 1, 2, 3 and 4]

3. Area under the plasma concentration-time curve from time zero to 72 hours post-dose [AUC(0-72)] of BMS-955176 [Days 1-4 of Periods 1, 2, 3 and 4]

Secondary Outcome Measures

1. Time of maximum observed plasma concentration (Tmax) of BMS-955176 [Days 1-4 of Periods 1, 2, 3 and 4]

2. Terminal plasma half-life (T-HALF) of BMS-955176 [Days 1-4 of Periods 1, 2, 3 and 4]

3. Apparent total body clearance (CLT/F) of BMS-955176 [Days 1-4 of Periods 1, 2, 3 and 4]

4. 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 [Up to Period 4/Day 4 (discharge)]

Eligibility Criteria

Criteria

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Nottingham		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: NCT02095886
• Other Study ID Numbers: 206740; 2013-004896-10; AI468-034
• First Posted: Mar 26, 2014
• Last Update Posted: Sep 11, 2017
• Last Verified: Sep 1, 2017

• Additional relevant MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; BMS-955176

Study Results

No Results Posted as of Sep 11, 2017