Absolute Bioavailability of BMS-791325

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Hepatitis C Virus Infection

Treatments: Drug: BMS-791325; Drug: [13C]-BMS-791325

Study type: Interventional

Funder types: Industry

Identifiers

NCT02112110

AI443-109

2013-004645-17 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine the absolute bioavailability of 150 mg oral dose of BMS-791325 relative to 100 µg IV infusion of [13C]-BMS-791325.

Full description

Primary Purpose: Other: Protocol is designed to assess the absolute bioavailability of 150 mg (2x75 mg tablets) BMS-791325 administered orally

Enrollment: 8 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:

1. Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations

2. Men and women ages 18 to 49 years, inclusive

3. Women of childbearing potential (WOCBP) must not be pregnant or breastfeeding

   • WOCBP and men who are sexually active with WOCBP must agree to follow protocol mandated instructions for method(s) of contraception during and after the study

Exclusion Criteria:

1. Any significant acute or chronic medical illness
2. Any current or recent gastrointestinal disease or surgery that could impact upon the absorption of study drug
3. Inability to tolerate oral medication
4. Inability to be venipunctured and/or tolerate venous access
5. Use of tobacco-containing or nicotine-containing products within 6 months
6. Recent (within 6 months of study drug administration) drug or alcohol abuse as defined in Diagnostic and Statistical Manual of Mental Disorders (4th Edition)(DSM IV), Diagnostic Criteria for Drug and Alcohol Abuse
7. Any of the following on 12-lead electrocardiogram (ECG) prior to study drug administration at screening or Day -1, confirmed by repeat

i)PR ≥ 210 msec

ii)QRS ≥ 120 msec

iii)QT ≥ 500 msec

iv)QTcF ≥ 450 msec

v)Second or third degree heart block

h) Positive urine screen for drugs of abuse

i) Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, r HIV-1, -2 antibodies

j) Any of the following screening or Day -1 laboratory results outside the ranges specified below as defined by the laboratory, confirmed by repeat analysis:

i)Serum creatinine > upper limit of normal (ULN)

ii)Alanine aminotransferase (ALT) > ULN

iii)Aspartate aminotransferase(AST) > ULN

iv)Total bilirubin > ULN

k) History of any significant drug allergy (such as anaphylaxis or hepatotoxicity)

Trial design

8 participants in 1 patient group

BMS-791325 (oral) and [13C]-BMS-791325 (IV)

Experimental group

Description:

BMS-791325 single dose tablet orally and \[13C\]-BMS-791325 single dose solution intravenously on specific days

Treatment:

Drug: [13C]-BMS-791325

Drug: BMS-791325