Back to results

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

Primary Purpose

Infection, Human Immunodeficiency Virus

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

BMS-955176, Placebo (Part 1)

BMS-955176, Moxifloxacin, Placebo (Part 2)

About this trial

This is an interventional other trial for Infection, Human Immunodeficiency Virus

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Part 1: Sentinal Cohorts

Part 2: Main QTc Study

Arm 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.

3 period nested crossover study.

Outcomes

Primary Outcome Measures

Part 1: Reported adverse events

Part 1: Vital sign measurements

Part 1: Physical examinations

Part 1: Safety 12-lead ECGs

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02576119

First Posted

October 13, 2015

Last Updated

August 7, 2017

Sponsor

ViiV Healthcare

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT02576119

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Terminated

Why Stopped

This study was terminated early due to neuropsychiatric serious adverse events reported by 2 participants.

Study Start Date

October 19, 2015 (Actual)

Primary Completion Date

February 26, 2016 (Actual)

Study Completion Date

October 14, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ViiV Healthcare

Collaborators

GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infection, Human Immunodeficiency Virus

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

315 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part 1: Sentinal Cohorts

Arm Type

Experimental

Arm 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.

Arm Title

Part 2: Main QTc Study

Arm Type

Experimental

Arm Description

3 period nested crossover study.

Intervention Type

Drug

Intervention Name(s)

BMS-955176, Placebo (Part 1)

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

BMS-955176, Moxifloxacin, Placebo (Part 2)

Intervention Description

Subjects will be randomized to 1 of 12 sequences. Each sequence includes combination of different regimens (combination of BMS-955176, placebo and Moxifloxacin).

Primary Outcome Measure Information:

Title

Part 1: Reported adverse events

Time Frame

Selected time points up to 24 hours postdose

Title

Part 1: Vital sign measurements

Time Frame

Selected time points up to 24 hours postdose

Title

Part 1: Physical examinations

Time Frame

Selected time points up to 24 hours postdose

Title

Part 1: Safety 12-lead ECGs

Time Frame

Selected time points up to 24 hours postdose

Title

Time Frame

Days 1 to 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

ViiV Healthcare

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78744

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs