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

ViiV Healthcare

Status and phase: Terminated; Phase 1

Conditions: Infection, Human Immunodeficiency Virus

Treatments: Drug: BMS-955176, Moxifloxacin, Placebo (Part 2); Drug: BMS-955176, Placebo (Part 1)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02576119

206220

AI468-044 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 315 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Written Informed Consent
2. 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
3. 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
4. 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
5. 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

1. Any significant acute or chronic medical illness
2. Any GI disease or surgery that can affect absorption of the study drug
3. 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)
4. 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
5. History of allergy to moxifloxacin, HIV maturation inhibitors, or related compounds

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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315 participants in 2 patient groups

Part 1: Sentinal Cohorts

Experimental group

Description:

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.

Treatment:

Drug: BMS-955176, Placebo (Part 1)

Part 2: Main QTc Study

Experimental group

Description:

3 period nested crossover study.

Treatment:

Drug: BMS-955176, Moxifloxacin, Placebo (Part 2)