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| Name | Class |
|---|---|
| Kyowa Hakko Kirin Pharma, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Istradefylline 40mg | Experimental | Period 1: Day 1, istradefylline 40mg then crossover to Period 2 |
|
| Rifampin 300mg BID + istradefylline 40mg | Experimental | Period 2: Days 1-20 rifampin 300mg BID + istradefylline 40mg Day 8 only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Istradefylline 40 mg | Drug | On Day 1, istradefylline 1 × 40-mg tablet administered alone |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of serious adverse events, and non-serious adverse events | Continuously for up to 74 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Cantillon, M.D. | Kyowa Hakko Kirin Pharma, Inc. | Study Chair |
| Amy Zhang, PhD | Kyowa Hakko Kirin Pharma, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion, Inc. | Tempe | Arizona | 85283 | United States |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C111599 | istradefylline |
| D012293 | Rifampin |
| C494814 | BID protein, human |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Rifampin 300mg BID + istradefylline 40mg Day 8 only | Drug | On Days 1 - 20, rifampin 300mg BID; On Day 8, istradefylline 40 mg administered first with rifampin about 2 hours after istradefylline administration |
|
|
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |