A Study to Determine the Effect of Multiple Doses of BMS-955176 on the Electrocardiograph of Healthy Subjects

Study Overview
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Brief Summary
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The purpose of the study is to determine the effect of multiple doses of BMS-955176 on the QT interval corrected with Fridericia's method (QTcF) in healthy subjects.

Official Title
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A Randomized, Double-Blind, Double-Dummy, Positive-Controlled, Crossover Study to Determine Electrocardiographic Effects of BMS-955176 in Healthy Subjects

Conditions
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Infection, Human Immunodeficiency Virus

Intervention / Treatment
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* Drug: BMS-955176, Placebo (Part 1)
* Drug: BMS-955176, Moxifloxacin, Placebo (Part 2)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written Informed Consent Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination findings, 12-lead ECG measurements, physical measurements, and clinical laboratory test results Body mass index (BMI) of 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening and Day 1. BMI = weight (kg)/[height(m)]2 Women must have a negative serum pregnancy test, must not be breastfeeding, and women of child bearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-955176 in addition to a post-treatment completion period Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-955176 in addition to a post-treatment completion period Exclusion Criteria: Any significant acute or chronic medical illness Any GI disease or surgery that can affect absorption of the study drug A personal history of clinically relevant cardiac disease, long QT syndrome, symptomatic or asymptomatic arrhythmias, presyncope or syncopal episodes, or additional risk factors for torsades de pointes (eg, heart failure) Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population History of allergy to moxifloxacin, HIV maturation inhibitors, or related compounds

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1: Sentinal Cohorts<br>Study is in 2 sequential cohorts (BMS-955176 or placebo) each to evaluate the safety, tolerability, and PK following multiple-dose administration of BMS-955176. | Drug: BMS-955176, Placebo (Part 1)<br>* The BMS-955176 dose in sentinel Cohort 1 will be 240 mg orally. The BMS-955176 dose in sentinel Cohort 2 will be determined based on the results of data from sentinel Cohort 1.<br>|
| Experimental: Part 2: Main QTc Study<br>3 period nested crossover study. | Drug: BMS-955176, Moxifloxacin, Placebo (Part 2)<br>* Subjects will be randomized to 1 of 12 sequences. Each sequence includes combination of different regimens (combination of BMS-955176, placebo and Moxifloxacin).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part 1: Reported adverse events |  | Selected time points up to 24 hours postdose | 
| Part 1: Vital sign measurements |  | Selected time points up to 24 hours postdose | 
| Part 1: Physical examinations |  | Selected time points up to 24 hours postdose | 
| Part 1: Safety 12-lead ECGs |  | Selected time points up to 24 hours postdose | 
| Part 2: ΔΔQTcF, the subject specific time-matched difference between the ΔQTcF (QT interval corrected with Fridericia's method) after administration of BMS-955176 and the ΔQTcF after administration of placebo |  | Days 1 to 28 |