Japanese Bridging Study Conducted in the United States

Bristol-Myers Squibb (BMS)

Status and phase: Withdrawn; Phase 1

Conditions: Hepatitis C Virus

Treatments: Drug: Placebo; Drug: BMS-791325

Study type: Interventional

Funder types: Industry

Identifiers

NCT00947245

AI443-011

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics following single oral and multiple oral doses BMS-791325 in healthy Japanese subjects.

Sex: All

Ages: 20 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and female subjects aged 20 to 49 years, with BMI of 18-30 kg/m2
• First generation Japanese. Subject born in Japan and has not lived outside of Japan for > 10 years, and subject can trace maternal and paternal Japanese ancestry

Exclusion criteria

• Any significant acute or chronic medical illness.
• Women who are pregnant, breastfeeding, or unwilling or unable to use an acceptable method of birth control.
• Gastrointestinal disease that may impact the absorption of study drug or that required treatment with a protocon inhibitor, antacid or H2 blocker.
• History of eczema, psoriasis, or any intermittent or active dermatitis.
• Positive for HIV or HCV

Trial design

0 participants in 6 patient groups

BMS-791325 - Part A, Dose 1

Experimental group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: BMS-791325

Drug: BMS-791325

Drug: Placebo

Drug: Placebo

Drug: BMS-791325

Drug: BMS-791325

Drug: BMS-791325

Drug: BMS-791325

BMS-791325 - Part A, Dose 2

Experimental group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: BMS-791325

Drug: BMS-791325

Drug: Placebo

Drug: Placebo

Drug: BMS-791325

Drug: BMS-791325

Drug: BMS-791325

Drug: BMS-791325

BMS-791325 - Part A, Dose 3

Experimental group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: BMS-791325

Drug: BMS-791325

Drug: Placebo

Drug: Placebo

Drug: BMS-791325

Drug: BMS-791325

Drug: BMS-791325

Drug: BMS-791325

BMS-791325 - Part B, Dose 1

Experimental group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: BMS-791325

Drug: BMS-791325

Drug: Placebo

Drug: Placebo

Drug: BMS-791325

Drug: BMS-791325

Drug: BMS-791325

Drug: BMS-791325

BMS-791325 - Part B, Dose 2

Experimental group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: BMS-791325

Drug: BMS-791325

Drug: Placebo

Drug: Placebo

Drug: BMS-791325

Drug: BMS-791325

Drug: BMS-791325

Drug: BMS-791325

BMS-791325 - Part B, Dose 3

Experimental group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: BMS-791325

Drug: BMS-791325

Drug: Placebo

Drug: Placebo

Drug: BMS-791325

Drug: BMS-791325

Drug: BMS-791325

Drug: BMS-791325