Japanese Bridging Study Conducted in the United States

NCT00947245 | Withdrawn Phase 1

• 1 other identifier: AI443-011
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatitis C Virus

Outcome Measures

Primary Outcomes (1)

• Safety (adverse events, physical examinations, clinical labs, ECGs, vital signs)

  From time of dose to up to 14 days after last dose

Secondary Outcomes (1)

• To measure concentration of study drug following single and multiple doses

  Within 48 or 72 hours postdose

Study Arms (6)

BMS-791325 - Part A, Dose 1

EXPERIMENTAL

Drug: BMS-791325; Drug: Placebo

BMS-791325 - Part A, Dose 2

EXPERIMENTAL

Drug: BMS-791325; Drug: Placebo

BMS-791325 - Part A, Dose 3

EXPERIMENTAL

Drug: BMS-791325; Drug: Placebo

BMS-791325 - Part B, Dose 1

EXPERIMENTAL

Drug: BMS-791325; Drug: Placebo

BMS-791325 - Part B, Dose 2

EXPERIMENTAL

Drug: BMS-791325; Drug: Placebo

BMS-791325 - Part B, Dose 3

EXPERIMENTAL

Drug: BMS-791325; Drug: Placebo

Interventions

BMS-791325 DRUG

Capsules, Oral, 300 mg, Single Dose, One day

BMS-791325 - Part A, Dose 1

Placebo DRUG

Capsules, Oral, Single Dose, One day

BMS-791325 - Part A, Dose 1; BMS-791325 - Part A, Dose 2; BMS-791325 - Part A, Dose 3

Eligibility Criteria

• Age: 20 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution

Cypress, California, 90630, United States

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Hepatitis C

Interventions

8-cyclohexyl-N-((dimethylamino)sulfonyl)-1,1a,2,12b-tetrahydro-11-methoxy-1a-((3-methyl-3,8-diazabicyclo(3.2.1)oct-8-yl)carbonyl)cycloprop(d)indolo(2,1-a)(2)benzazepine-5-carboxamide

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2009
• First Posted: July 28, 2009
• Study Start: October 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: July 18, 2013

Record last verified: 2013-07

Locations

US (1)