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

Sponsor
ViiV Healthcare (Industry)
Overall Status
Terminated
CT.gov ID
NCT02576119
Collaborator
GlaxoSmithKline (Industry)
315
Enrollment
1
Location
2
Arms
11.9
Actual Duration (Months)
26.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: BMS-955176, Placebo (Part 1)
  • Drug: BMS-955176, Moxifloxacin, Placebo (Part 2)
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
315 participants
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
Actual Study Start Date :
Oct 19, 2015
Actual Primary Completion Date :
Feb 26, 2016
Actual Study Completion Date :
Oct 14, 2016

Arms and Interventions

Arm Intervention/Treatment
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).

Outcome Measures

Primary Outcome Measures

  1. Part 1: Reported adverse events [Selected time points up to 24 hours postdose]

  2. Part 1: Vital sign measurements [Selected time points up to 24 hours postdose]

  3. Part 1: Physical examinations [Selected time points up to 24 hours postdose]

  4. Part 1: Safety 12-lead ECGs [Selected time points up to 24 hours postdose]

  5. 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]

Eligibility Criteria

Criteria

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

Locations

Site City State Country Postal Code
1 GSK Investigational Site Austin Texas United States 78744

Sponsors and Collaborators

  • ViiV Healthcare
  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, ViiV Healthcare

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT02576119
Other Study ID Numbers:
  • 206220
  • AI468-044
First Posted:
Oct 15, 2015
Last Update Posted:
Aug 9, 2017
Last Verified:
Aug 1, 2017
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Moxifloxacin
BMS-955176

Study Results

No Results Posted as of Aug 9, 2017