Study to Determine the Effect of BMS-791325 on the ECG QTcF Interval in Healthy Subjects

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Hepatitis C

Treatments: Drug: Moxifloxacin; Drug: BMS-791325; Drug: Placebo matching BMS-791325

Study type: Interventional

Funder types: Industry

Identifiers

NCT02084953

AI443-112

Details and patient eligibility

About

The purpose of this study is to determine whether BMS-791325 has an effect on the electrocardiogram (ECG) interval QT corrected for Fridericia's method (QTcF).

Full description

Primary Purpose: Other: This Phase 1 study is a clinical pharmacology thorough QT study.

Enrollment: 59 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Healthy men and women, ages 18 to 49 yr old
• BMI 18 to 32
• Women must not be pregnant or breastfeeding

Exclusion Criteria:

• Any significant acute or chronic medical illness
• A personal history of clinically relevant cardiac disease, symptomatic or asymptomatic arrhythmias, presyncope or syncopal episodes, or additional risk factors for torsades de pointes (eg, heart failure)
• History of hypokalemia, personal history or family history of prolonged QT interval, or family history of sudden cardiac death at a young age
• History of biliary disorders, including Gilbert's disease or Dubin-Johnson disease
• Inability to swallow multiple tablets consecutively
• Any of the following on 12-lead electrocardiogram (ECG) prior to study drug administration: PR ≥ 210 msec, QRS ≥ 120 msec, QT ≥ 500 msec, QTcF ≥ 450 msec, Heart Rate (HR) < 45 bpm
• Second or third degree heart block prior to study drug
• Positive urine screen for drugs of abuse
• Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or Human Immunodeficiency Virus (HIV)-1, -2 antibody
• Any of the following lab results outside of the ranges specified below prior to dosing: Alanine aminotransferase (ALT) > upper limit of normal (ULN), Aspartate aminotransferase (AST) > ULN, Total bilirubin > ULN, Direct bilirubin > ULN, Creatinine > ULN, Serum potassium < lower limit of normal (LLN), Serum magnesium < LLN
• History of allergy to Moxifloxacin, BMS-791325, nonstructural protein 5B (NS5B) non-nucleoside inhibitors or related compounds

Trial design

59 participants in 3 patient groups, including a placebo group

ARM A: BMS-791325

Experimental group

Description:

BMS-791325 600 mg tablet orally on 1st and 2nd day, then 900 mg on the 3rd day once a day for 3 days

Treatment:

Drug: BMS-791325

ARM B: Moxifloxacin

Active Comparator group

Description:

Moxifloxacin 400mg tablet orally once on third day

Treatment:

Drug: Moxifloxacin

ARM C: Placebo matching BMS-791325

Placebo Comparator group

Description:

Placebo matching BMS-791325 0 mg tablet orally once daily for 3 days

Treatment:

Drug: Placebo matching BMS-791325