Clinical trial NCT02576119: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Infection, Human Immunodeficiency Virus
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2015-10-15
Enrollment: 315
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Part 1: Reported adverse events
timeFrame: Selected time points up to 24 hours postdose
measure: Part 1: Vital sign measurements
timeFrame: Selected time points up to 24 hours postdose
measure: Part 1: Physical examinations
timeFrame: Selected time points up to 24 hours postdose
measure: Part 1: Safety 12-lead ECGs
timeFrame: Selected time points up to 24 hours postdose
measure: 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
timeFrame: Days 1 to 28
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
affiliation: ViiV Healthcare
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: