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The purpose of this study is to investigate the effects of CYP3A4/5 inhibitor or inducer on the pharmacokinetics of KW-6356 when CYP3A4/5 inhibitor or inducer is orally administered to healthy Japanese men for 7 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clarithromycin | Experimental |
| |
| Rifampicin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KW-6356 | Drug | A single oral dose will be administered at Day 1 and 15 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean ratio of the pharmacokinetic parameter (AUC0-t) of KW-6356 in combination with or without a perpetrator drug | Starting just before intake of KW-6356 and continued until 168 or 336 hours after intake of KW-6356. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean ratio of the major pharmacokinetic parameters (Cmax) of KW-6356 in combination with or without a perpetrator drug | Starting just before intake of KW-6356 and continued until 168 or 336 hours after intake of KW-6356. | |
| Geometric mean ratio of the major pharmacokinetic parameters (AUC0-∞) of KW-6356 in combination with or without a perpetrator drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Co. LTA Sumida Hospital | Sumida-ku | Tokyo | Japan |
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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 |
|---|---|
| D017291 | Clarithromycin |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| Clarithromycin | Drug | 400mg, oral tablet (2 x 200mg), twice daily (BID), Day 8-28 |
|
| Rifampicin | Drug | 600mg, oral tablet (4 x 150mg), once daily (QD), Day 8-21 |
|
| Starting just before intake of KW-6356 and continued until 168 or 336 hours after intake of KW-6356. |
| Pharmacokinetic parameters (tmax) of KW-6356 | Starting just before intake of KW-6356 and continued until 168 or 336 hours after intake of KW-6356. |
| Pharmacokinetic parameters (CL/F) of KW-6356 | Starting just before intake of KW-6356 and continued until 168 or 336 hours after intake of KW-6356. |
| Pharmacokinetic parameters (Vz/F) of KW-6356 | Starting just before intake of KW-6356 and continued until 168 or 336 hours after intake of KW-6356. |
| Pharmacokinetic parameters (t1/2) of KW-6356 | Starting just before intake of KW-6356 and continued until 168 or 336 hours after intake of KW-6356. |
| Plasma concentrations of a perpetrator drug | Starting just before intake of a perpetrator drug at Day 8 and continued until 12 or 24 hours after the last dose of a perpetrator drug. |
| Incidence of treatment-emergent adverse events | Starting 24 hours before intake of KW-6356 and continued until 14 days after the last dose of a perpetrator drug. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| Organic Chemicals |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |