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 |
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.
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
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