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The purpose of this study is to evaluate the influence of repeated oral doses of KW-6356 on the pharmacokinetics of index substrates for CYP3A4/5, CYP1A2 and BCRP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KW-6356/Healthy Japanese adult male subjects | Experimental | Period 1: intake of the index substrates at Day 1 (Cohort 1: midazolam, Cohort 2: caffeine + rosuvastatin) followed by Period 2: intake of KW-6356 at Day 4-13, intake of the index substrates at Day 11 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug | In Period 1, Day 1 a single dose will be administered after fasting for at least 10 hours. In Period 2, Day 11 a single dose will be administered after fasting for at least 10 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean ratio of the major pharmacokinetic parameter (AUC0-t) of the index substrates in combination with or without KW-6356 | Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356 |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean ratio of the major pharmacokinetic parameters (Cmax) of the index substrates in combination with or without KW-6356 | Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356 | |
| Geometric mean ratio of the major pharmacokinetic parameters (AUC0-∞) of the index substrates in combination with or without KW-6356 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fukuoka Mirai Hospital Clinical Research Center | Fukuoka | 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 |
|---|---|
| D008874 | Midazolam |
| D002110 | Caffeine |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Caffeine | Drug | In Period 1, Day 1 a single dose will be administered after fasting for at least 10 hours. In Period 2, Day 11 a single dose will be administered after fasting for at least 10 hours. |
|
| Rosuvastatin | Drug | In Period 1, Day 1 a single dose will be administered after fasting for at least 10 hours. In Period 2, Day 11 a single dose will be administered after fasting for at least 10 hours. |
|
| KW-6356 | Drug | In Period 2, Day 4-13(except Day11) a single dose of KW-6356 will be administered after breakfast, Day 11 a single dose of KW-6356 will be administered after fasting for at least 10 hours. |
|
| Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356 |
| Pharmacokinetic parameters (tmax) of the index substrates | Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356 |
| Pharmacokinetic parameters (CL/F) of the index substrates | Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356 |
| Pharmacokinetic parameters (Vz/F) of the index substrates | Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356 |
| Pharmacokinetic parameters (t1/2) of the index substrates | Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356 |
| Plasma concentrations of the index substrates | Starting around 2 hours before intake of the index substrates and continued until 24 hours after the last dose of KW-6356 |
| Plasma concentrations of KW-6356 | Starting around 2 hours before intake of KW-6356 and continued until 24 hours after the last dose of KW-6356 |
| Incidence of treatment-emergent adverse events | Starting 24 or 48 hours before intake of the index substrates and continued until 8 days after the last dose of KW-6356 |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D006571 | Heterocyclic Compounds |
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D011688 | Purinones |
| D011687 | Purines |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |