The Effect of Rifampin on the Metabolism of Istradefylline in Healthy Volunteers.
Study Details
Study Description
Brief Summary
The purpose of this study is to test whether Rifampin affects blood levels of istradefylline in humans. Rifampin could possibly decrease istradefylline levels.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Istradefylline 40mg Period 1: Day 1, istradefylline 40mg then crossover to Period 2 |
Drug: Istradefylline 40 mg
On Day 1, istradefylline 1 × 40-mg tablet administered alone
Other Names:
|
| Experimental: Rifampin 300mg BID + istradefylline 40mg Period 2: Days 1-20 rifampin 300mg BID + istradefylline 40mg Day 8 only |
Drug: Istradefylline 40 mg
On Day 1, istradefylline 1 × 40-mg tablet administered alone
Other Names:
Drug: Rifampin 300mg BID + istradefylline 40mg Day 8 only
On Days 1 - 20, rifampin 300mg BID; On Day 8, istradefylline 40 mg administered first with rifampin about 2 hours after istradefylline administration
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Area under the concentration-time curve from time zero to infinity (AUC0 ∞) and Observed maximum plasma concentration (Cmax) of istradefylline [Intermittently for a total of 62 days]
Secondary Outcome Measures
- Number of serious adverse events, and non-serious adverse events [Continuously for up to 74 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy non-smoking male and post-menopausal female subjects
-
Body Mass Index: 18.0-35.0 kg/m2, inclusive
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Subjects must not be taking drugs that are moderate to potent inhibitors of CYP3A4 or CYP1A2.
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Subjects without clinically significant medical history in the judgment of the investigator
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Subjects without clinically significant laboratory or ECG abnormalities
Exclusion Criteria:
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Females that are pregnant or lactating
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Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study;
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Known history of treatment for drug or alcohol addiction within the previous 12 months;
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Subjects with an average alcohol intake of more than 2 units per day or 14 units per week up to 48 hours prior to the istradefylline dose on Day 1. One unit of alcohol is ½ pint of beer (285 mL) or 1 glass of spirits (25 mL) or 1 glass of wine (125 mL);
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Donated or lost > 500 mL of blood within 3 months prior to istradefylline dose on Day 1 of Period 1;
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Positive test results for human immunodeficiency virus (HIV) or Hepatitis B surface antigen, or Hepatitis C;
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Positive test results for drugs of abuse at screening;
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Unable, or unwilling to tolerate multiple venipunctures;
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Difficulty fasting or eating the standard meals that will be provided;
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Use of tobacco or nicotine-containing products within 90 days of the study start to the Follow-up visit
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Celerion, Inc. | Tempe | Arizona | United States | 85283 |
Sponsors and Collaborators
- Kyowa Hakko Kirin Pharma, Inc.
Investigators
- Study Chair: Marc Cantillon, M.D., Kyowa Hakko Kirin Pharma, Inc.
- Study Director: Amy Zhang, PhD, Kyowa Hakko Kirin Pharma, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 6002-015