Trials / Completed
CompletedNCT02676596
Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of K-312 in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- Kowa Research Institute, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to investigate the safety tolerability, and PK profile of K-312 and its metabolites in healthy Japanese and non-Japanese adults.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | K-312 10 mg QD | |
| DRUG | K-312 25 mg QD | |
| DRUG | K-312 50 mg QD | |
| DRUG | K-312 100 mg QD | |
| DRUG | K-312 200 mg QD | |
| DRUG | K-312 400 mg QD | |
| OTHER | Placebo |
Timeline
- Start date
- 2014-04-01
- Primary completion
- 2014-11-01
- Completion
- 2015-01-01
- First posted
- 2016-02-08
- Last updated
- 2016-02-12
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02676596. Inclusion in this directory is not an endorsement.