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WithdrawnNCT00947245Updated Jul 18, 2013

Japanese Bridging Study Conducted in the United States

A Phase 1 interventional study of BMS-791325 and BMS-791325 in Hepatitis C Virus, sponsored by Bristol-Myers Squibb. Withdrawn at 1 site in United States. Open to participants aged 20 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-07-18.

Sponsored by Bristol-Myers Squibb · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
20 Years to 49 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hepatitis C Virus

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03

In context

Hepatitis C

2,356 studies on the registry are indexed under Hepatitis C; 101 are open to participants now.

Browse Hepatitis C studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,562 studies on the registry; 118 are open to participants now.

Of its 435 completed or terminated interventional studies of FDA-regulated products, 227 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 49 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    BMS-791325 - Part A, Dose 1

    Drug: BMS-791325 · Drug: Placebo

  • Experimental
    BMS-791325 - Part A, Dose 2

    Drug: BMS-791325 · Drug: Placebo

  • Experimental
    BMS-791325 - Part A, Dose 3

    Drug: BMS-791325 · Drug: Placebo

  • Experimental
    BMS-791325 - Part B, Dose 1

    Drug: BMS-791325 · Drug: Placebo

  • Experimental
    BMS-791325 - Part B, Dose 2

    Drug: BMS-791325 · Drug: Placebo

  • Experimental
    BMS-791325 - Part B, Dose 3

    Drug: BMS-791325 · Drug: Placebo

Interventions

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

  • Capsules, Oral, 900 mg, Single Dose, One day

  • Capsules, Oral, ≤1200 mg, Single Dose, One day

  • Capsules, Oral, 300 mg, Every 12 hours, 14 days

  • Capsules, Oral, 900 mg, once daily 14 days

  • Capsules, Oral, ≤1200 mg, Every 12 hours or once daily, 14 days

  • DrugPlacebo

    Capsules, Oral, Single Dose, One day

  • DrugPlacebo

    Capsules, Oral, Every 12 hours, 14 days

  • DrugPlacebo

    Capsules, Oral, Once Daily, 14 days

  • DrugPlacebo

    Capsules, Oral, Every 12 hours or once daily, 14 days

06

What researchers measure

Primary outcomes

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

    Time frame: 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

    Time frame: Within 48 or 72 hours postdose

07

Study locations

1 site
  • Local Institution
    Cypress, California 90630, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00947245
Responsible party
Sponsor
First posted
Jul 28, 2009
Start date
Oct 2014
Primary completion
Feb 2015 (estimated)
Completion
Feb 2015 (estimated)
Last update
Jul 18, 2013

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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