Clinical Trials

MainTitle

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

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

Sponsor
ViiV Healthcare

Collaborator
GlaxoSmithKline

Information provided by (Responsible Party)
ViiV Healthcare
ClinicalTrials.gov Identifier
NCT02576119

First received: October 13, 2015
Last updated: August 7, 2017
Last Verified: August 2017
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
Infection, Human Immunodeficiency Virus

Drug : BMS-955176, Placebo (Part 1)
Drug : BMS-955176, Moxifloxacin, Placebo (Part 2)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: A Randomized, Double-Blind, Double-Dummy, Positive-Controlled, Crossover Study to Determine Electrocardiographic Effects of BMS-955176 in Healthy Subjects

Further study details as provided by ViiV Healthcare:

Primary Outcome Measures

  • 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 ]

Enrollment: 315
Study Start Date: October 19, 2015
Study Completion Date: October 14, 2016
Estimated Primary Completion Date: February 26, 2016 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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).

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 49 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: Yes  

Criteria

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02576119

Locations

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

Sponsors and Collaborators

ViiV Healthcare
GlaxoSmithKline

Investigators

Study Director: GSK Clinical Trials ViiV Healthcare
More Information

More Information


Responsible Party: ViiV Healthcare  
ClinicalTrials.gov Identifier: NCT02576119   History of Changes  
Other Study ID Numbers: 206220  
  AI468-044  
Study First Received: October 13, 2015  
Last Updated: August 7, 2017  

Studies a U.S. FDA-regulated Drug Product: Yes  
Studies a U.S. FDA-regulated Device Product: No  

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination

ClinicalTrials.gov processed this data on December 18, 2017
This information is provided by ClinicalTrials.gov.