Trials / Completed
CompletedNCT04070495
A Drug Interaction Study of KW-6356 and Clarithromycin or Rifampicin
A Drug Interaction Study of KW-6356 and Clarithromycin or Rifampicin (A Drug Interaction Study With a CYP3A4/5 Inhibitor or Inducer)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KW-6356 | A single oral dose will be administered at Day 1 and 15 |
| DRUG | Clarithromycin | 400mg, oral tablet (2 x 200mg), twice daily (BID), Day 8-28 |
| DRUG | Rifampicin | 600mg, oral tablet (4 x 150mg), once daily (QD), Day 8-21 |
Timeline
- Start date
- 2019-08-27
- Primary completion
- 2019-11-19
- Completion
- 2019-11-19
- First posted
- 2019-08-28
- Last updated
- 2019-11-29
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT04070495. Inclusion in this directory is not an endorsement.