A Study to Determine the Effect of Multiple Doses of BMS-955176 on the Electrocardiograph of Healthy Subjects
|ClinicalTrials.gov Identifier: NCT02576119|
Recruitment Status : Terminated (This study was terminated early due to neuropsychiatric serious adverse events reported by 2 participants.)
First Posted : October 15, 2015
Last Update Posted : August 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Infection, Human Immunodeficiency Virus||Drug: BMS-955176, Placebo (Part 1) Drug: BMS-955176, Moxifloxacin, Placebo (Part 2)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||315 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized, Double-Blind, Double-Dummy, Positive-Controlled, Crossover Study to Determine Electrocardiographic Effects of BMS-955176 in Healthy Subjects|
|Actual Study Start Date :||October 19, 2015|
|Actual Primary Completion Date :||February 26, 2016|
|Actual Study Completion Date :||October 14, 2016|
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).
- Part 1: Reported adverse events [ Time Frame: Selected time points up to 24 hours postdose ]
- Part 1: Vital sign measurements [ Time Frame: Selected time points up to 24 hours postdose ]
- Part 1: Physical examinations [ Time Frame: Selected time points up to 24 hours postdose ]
- Part 1: Safety 12-lead ECGs [ Time Frame: 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 [ Time Frame: Days 1 to 28 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02576119
|United States, Texas|
|GSK Investigational Site|
|Austin, Texas, United States, 78744|
|Study Director:||GSK Clinical Trials||ViiV Healthcare|