NCT00947245WithdrawnPhase 1
A Randomized, Placebo-Controlled, Single and Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BMS-791325 in Healthy Japanese Subjects
Bristol-Myers Squibb1 site in 1 countryStarted: October 2014Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- Safety (adverse events, physical examinations, clinical labs, ECGs, vital signs)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 49 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
BMS-791325 - Part B, Dose 3
Experimental
Intervention: Placebo (Drug)
BMS-791325 - Part A, Dose 1
Experimental
Intervention: BMS-791325 (Drug)
BMS-791325 - Part A, Dose 1
Experimental
Intervention: Placebo (Drug)
BMS-791325 - Part A, Dose 2
Experimental
Intervention: BMS-791325 (Drug)
BMS-791325 - Part A, Dose 2
Experimental
Intervention: Placebo (Drug)
BMS-791325 - Part A, Dose 3
Experimental
Intervention: BMS-791325 (Drug)
BMS-791325 - Part A, Dose 3
Experimental
Intervention: Placebo (Drug)
BMS-791325 - Part B, Dose 1
Experimental
Intervention: BMS-791325 (Drug)
BMS-791325 - Part B, Dose 1
Experimental
Intervention: Placebo (Drug)
BMS-791325 - Part B, Dose 2
Experimental
Intervention: BMS-791325 (Drug)
BMS-791325 - Part B, Dose 2
Experimental
Intervention: Placebo (Drug)
BMS-791325 - Part B, Dose 3
Experimental
Intervention: BMS-791325 (Drug)
Outcomes
Primary Outcomes
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
- To measure concentration of study drug following single and multiple doses(Within 48 or 72 hours postdose)
Investigators
Study Sites (1)
Loading locations...
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