drugset / Trial / NCT01813448
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Fidaxomicin in Healthy Male Japanese and Caucasian Subjects
Phase 1
Completed
36 enrolled
Astellas Pharma Global Development, Inc.
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · collab
RandomizedParallel-groupQuadruple-blind
Summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of single and multiple ascending doses of fidaxomicin in healthy subjects. This study will also compare the safety, tolerability and PK of single and multiple doses of fidaxomicin in healthy Japanese and Caucasian subjects.
Timeline
- Start
- 2013-02
- Primary completion
- 2013-04
- Completion
- 2013-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fidaxomicin | Other / unclassified | — | Oral |
Indications
No indication recorded.