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

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

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.

Study Overview

• Status: Terminated
• Conditions: Infection, Human Immunodeficiency Virus
• Intervention / Treatment: Drug: BMS-955176, Placebo (Part 1); Drug: BMS-955176, Moxifloxacin, Placebo (Part 2)

• Study Type: Interventional
• Enrollment (Actual): 315
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Sentinal Cohorts; 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); 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.
Experimental: Part 2: Main QTc Study; 3 period nested crossover study.	Drug: BMS-955176, Moxifloxacin, Placebo (Part 2); Subjects will be randomized to 1 of 12 sequences. Each sequence includes combination of different regimens (combination of BMS-955176, placebo and Moxifloxacin).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: ViiV Healthcare
• Collaborators: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2015
• Primary Completion (Actual): February 26, 2016
• Study Completion (Actual): October 14, 2016

Study Registration Dates

• First Submitted: October 13, 2015
• First Submitted That Met QC Criteria: October 13, 2015
• First Posted (Estimate): October 15, 2015

Study Record Updates

• Last Update Posted (Actual): August 9, 2017
• Last Update Submitted That Met QC Criteria: August 7, 2017
• Last Verified: August 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; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Moxifloxacin; BMS-955176
• Other Study ID Numbers: 206220; AI468-044 (Other Identifier: Bristol-Myers Squibb)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No