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



Status:Recruiting
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 49
Updated:4/21/2016
Start Date:October 2015
End Date:June 2016
Contact:Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
Email:Clinical.Trials@bms.com

Use our guide to learn which trials are right for you!

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

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.


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
We found this trial at
1
site
Austin, Texas 78744
?
mi
from
Austin, TX
Click here to add this to my saved trials