The Effect of Rifampin on the Metabolism of Istradefylline in Healthy Volunteers.

Study Overview
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Brief Summary
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The purpose of this study is to test whether Rifampin affects blood levels of istradefylline in humans. Rifampin could possibly decrease istradefylline levels.

Official Title
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Effect of a Strong Enzyme Inducer, Rifampin, on the Single-Dose Pharmacokinetics of Istradefylline in Healthy Subjects

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: Istradefylline 40 mg
* Drug: Rifampin 300mg BID + istradefylline 40mg Day 8 only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy non-smoking male and post-menopausal female subjects Body Mass Index: 18.0-35.0 kg/m2, inclusive Subjects must not be taking drugs that are moderate to potent inhibitors of CYP3A4 or CYP1A2. Subjects without clinically significant medical history in the judgment of the investigator Subjects without clinically significant laboratory or ECG abnormalities Exclusion Criteria: Females that are pregnant or lactating 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; Known history of treatment for drug or alcohol addiction within the previous 12 months; 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); Donated or lost > 500 mL of blood within 3 months prior to istradefylline dose on Day 1 of Period 1; Positive test results for human immunodeficiency virus (HIV) or Hepatitis B surface antigen, or Hepatitis C; Positive test results for drugs of abuse at screening; Unable, or unwilling to tolerate multiple venipunctures; Difficulty fasting or eating the standard meals that will be provided; Use of tobacco or nicotine-containing products within 90 days of the study start to the Follow-up visit

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Istradefylline 40mg<br>Period 1: Day 1, istradefylline 40mg then crossover to Period 2 | Drug: Istradefylline 40 mg<br>* On Day 1, istradefylline 1 × 40-mg tablet administered alone<br>* Other names: KW-6002;|
| Experimental: Rifampin 300mg BID + istradefylline 40mg<br>Period 2: Days 1-20 rifampin 300mg BID + istradefylline 40mg Day 8 only | Drug: Istradefylline 40 mg<br>* On Day 1, istradefylline 1 × 40-mg tablet administered alone<br>* Other names: KW-6002;Drug: Rifampin 300mg BID + istradefylline 40mg Day 8 only<br>* On Days 1 - 20, rifampin 300mg BID; On Day 8, istradefylline 40 mg administered first with rifampin about 2 hours after istradefylline administration<br>* Other names: rifadin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of serious adverse events, and non-serious adverse events |  | Continuously for up to 74 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PD