Trials / Completed
CompletedNCT03970798
A Drug Interaction Study of KW-6356 With Midazolam, Caffeine, or Rosuvastatin
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Kyowa Kirin Co., Ltd. · Industry
- Sex
- Male
- Age
- 20 Years – 44 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Midazolam | 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. |
| DRUG | Caffeine | 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. |
| DRUG | Rosuvastatin | 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. |
| DRUG | KW-6356 | 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. |
Timeline
- Start date
- 2019-05-22
- Primary completion
- 2019-07-31
- Completion
- 2019-07-31
- First posted
- 2019-06-03
- Last updated
- 2019-11-29
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT03970798. Inclusion in this directory is not an endorsement.