Absolute Bioavailability of BMS-791325

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-05-31

Brief Summary

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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.

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Detailed Description

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

Conditions

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Hepatitis C Virus Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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

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

Group Type EXPERIMENTAL

BMS-791325

Intervention Type DRUG

[13C]-BMS-791325

Intervention Type DRUG

Interventions

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BMS-791325

Intervention Type DRUG

[13C]-BMS-791325

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes