Relative Bioavailability Study With BMS-955176

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

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.

Study Overview

• Status: Completed
• Conditions: Infection, Human Immunodeficiency Virus
• Intervention / Treatment: Drug: BMS-955176

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 Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG11 6JS
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum observed plasma concentration (Cmax) of BMS-955176	Days 1-4 of Periods 1, 2, 3 and 4
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
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

Outcome Measure	Time Frame
Time of maximum observed plasma concentration (Tmax) of BMS-955176	Days 1-4 of Periods 1, 2, 3 and 4
Terminal plasma half-life (T-HALF) of BMS-955176	Days 1-4 of Periods 1, 2, 3 and 4
Apparent total body clearance (CLT/F) of BMS-955176	Days 1-4 of Periods 1, 2, 3 and 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)

Collaborators and Investigators

• Sponsor: ViiV Healthcare
• Collaborators: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2014
• Primary Completion (Actual): July 7, 2014
• Study Completion (Actual): July 7, 2014

Study Registration Dates

• First Submitted: March 21, 2014
• First Submitted That Met QC Criteria: March 21, 2014
• First Posted (Estimate): March 26, 2014

Study Record Updates

• Last Update Posted (Actual): September 11, 2017
• Last Update Submitted That Met QC Criteria: September 7, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; BMS-955176
• Other Study ID Numbers: 206740; 2013-004896-10 (EudraCT Number); AI468-034 (Other Identifier: Bristol-Myers Squibb)