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

Phase 1

Terminated

• Conditions: Infection, Human Immunodeficiency Virus
• Interventions: Drug: BMS-955176, Moxifloxacin, Placebo (Part 2); Drug: BMS-955176, Placebo (Part 1)

• Registration Number: NCT02576119
• Lead Sponsor: ViiV Healthcare

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-13
• Study First Submitted QC: 2015-10-13
• Study First Posted: 2015-10-15
• Study Start: 2015-10-19
• Primary Completion: 2016-02-26
• Study Completion: 2016-10-14
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-07
• Last Update Posted: 2017-08-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 315

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Part 2: Main QTc Study	BMS-955176, Moxifloxacin, Placebo (Part 2)	3 period nested crossover study.
Part 1: Sentinal Cohorts	BMS-955176, Placebo (Part 1)	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.

Primary Outcome Measures

Name	Time	Method
Part 1: Safety 12-lead ECGs	Selected time points up to 24 hours postdose
Part 1: Physical examinations	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
Part 1: Vital sign measurements	Selected time points up to 24 hours postdose
Part 1: Reported adverse events	Selected time points up to 24 hours postdose

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Austin, Texas, United States