Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03970798 | A Drug Interaction Study of KW-6356 With Midazolam, Caffeine, or Rosuvastatin | PHASE1 | COMPLETED | 50 | — | — | May 22, 2019 | Jul 31, 2019 | Nov 29, 2019 | 1 | Japan |
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| 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. |
| 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. |
Inclusion Criteria: 1. Individuals having issued written consent to this study at their own discretion 2. Japanese males aged 20 to 44 years at the time of informed consent 3. Body mass index (BMI) of 18.5 to \<25.0 at screening 4. Resting pulse rate of 40 to 100 bpm, systolic blood pressure of 90 ...