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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00947245
Other study ID # AI443-011
Secondary ID
Status Withdrawn
Phase Phase 1
First received July 27, 2009
Last updated July 17, 2013
Start date October 2014
Est. completion date February 2015

Study information

Verified date July 2013
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 49 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)


Related Conditions & MeSH terms


Intervention

Drug:
BMS-791325
Capsules, Oral, 300 mg, Single Dose, One day
BMS-791325
Capsules, Oral, 900 mg, Single Dose, One day
BMS-791325
Capsules, Oral, =1200 mg, Single Dose, One day
BMS-791325
Capsules, Oral, 300 mg, Every 12 hours, 14 days
BMS-791325
Capsules, Oral, 900 mg, once daily 14 days
BMS-791325
Capsules, Oral, =1200 mg, Every 12 hours or once daily, 14 days
Placebo
Capsules, Oral, Single Dose, One day
Placebo
Capsules, Oral, Every 12 hours, 14 days
Placebo
Capsules, Oral, Once Daily, 14 days
Placebo
Capsules, Oral, Every 12 hours or once daily, 14 days

Locations

Country Name City State
United States Local Institution Cypress California

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety (adverse events, physical examinations, clinical labs, ECGs, vital signs) From time of dose to up to 14 days after last dose Yes
Secondary To measure concentration of study drug following single and multiple doses Within 48 or 72 hours postdose No
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