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

Infection, Human Immunodeficiency Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02576119
• Other study ID #: 206220
• Secondary ID: AI468-044
• Status: Terminated
• Phase: Phase 1
• First received: October 13, 2015
• Last updated: August 7, 2017
• Start date: October 19, 2015
• Est. completion date: October 14, 2016

Study information

• Verified date: August 2017
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 315
• Est. completion date: October 14, 2016
• Est. primary completion date: February 26, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes
• Infection, Human Immunodeficiency Virus

Intervention

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.
• 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).

Locations

Country	Name	City	State
United States	GSK Investigational Site	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
ViiV Healthcare	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

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