Japanese Bridging Study Conducted in the United States
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| ClinicalTrials.gov Identifier: NCT00947245 |
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Recruitment Status :
Withdrawn
First Posted : July 28, 2009
Last Update Posted : July 18, 2013
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
- Study Details
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hepatitis C Virus | Drug: BMS-791325 Drug: Placebo | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 0 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Official Title: | A Randomized, Placebo-Controlled, Single and Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BMS-791325 in Healthy Japanese Subjects |
| Study Start Date : | October 2014 |
| Estimated Primary Completion Date : | February 2015 |
| Estimated Study Completion Date : | February 2015 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: BMS-791325 - Part A, Dose 1 |
Drug: BMS-791325
Capsules, Oral, 300 mg, Single Dose, One day Drug: Placebo Capsules, Oral, Single Dose, One day |
| Experimental: BMS-791325 - Part A, Dose 2 |
Drug: BMS-791325
Capsules, Oral, 900 mg, Single Dose, One day Drug: Placebo Capsules, Oral, Single Dose, One day |
| Experimental: BMS-791325 - Part A, Dose 3 |
Drug: BMS-791325
Capsules, Oral, ≤1200 mg, Single Dose, One day Drug: Placebo Capsules, Oral, Single Dose, One day |
| Experimental: BMS-791325 - Part B, Dose 1 |
Drug: BMS-791325
Capsules, Oral, 300 mg, Every 12 hours, 14 days Drug: Placebo Capsules, Oral, Every 12 hours, 14 days |
| Experimental: BMS-791325 - Part B, Dose 2 |
Drug: BMS-791325
Capsules, Oral, 900 mg, once daily 14 days Drug: Placebo Capsules, Oral, Once Daily, 14 days |
| Experimental: BMS-791325 - Part B, Dose 3 |
Drug: BMS-791325
Capsules, Oral, ≤1200 mg, Every 12 hours or once daily, 14 days Drug: Placebo Capsules, Oral, Every 12 hours or once daily, 14 days |
Primary Outcome Measures :
- 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 Outcome Measures :
- To measure concentration of study drug following single and multiple doses [ Time Frame: Within 48 or 72 hours postdose ]
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| Ages Eligible for Study: | 20 Years to 49 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00947245
Locations
| United States, California | |
| Local Institution | |
| Cypress, California, United States, 90630 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
BMS clinical trial educational resource
Investigator Inquiry form
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
Investigator Inquiry form
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00947245 History of Changes |
| Other Study ID Numbers: |
AI443-011 |
| First Posted: | July 28, 2009 Key Record Dates |
| Last Update Posted: | July 18, 2013 |
| Last Verified: | July 2013 |
Additional relevant MeSH terms:
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Hepatitis C Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections |
RNA Virus Infections Hepatitis Liver Diseases Digestive System Diseases |