drugset / Trial / NCT01874366
Determination of Safety,Tolerability,Pharmacokinetics,Food Effect& Pharmacodynamics of Single & Multiple Doses of P11187
Phase 1
Unknown
96 enrolled
Piramal Enterprises Limited
Miami Research Associates · collabQuintiles, Inc. · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
* Study to Determine the Safety, Tolerability, Pharmacokinetics, Food Effect and Pharmacodynamics of Single and Multiple Ascending Doses of P11187 * It will be conducted in three parts, as described below: * Part I will be the Single Ascending Dose (SAD) study * Part II will be the Multiple Ascending Dose (MAD) study * Part III will be the food effect evaluation
Timeline
- Start
- 2013-06
- Primary completion
- 2015-10
- Completion
- 2015-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | P11187 | Unknown | 10 mg | Oral |
| Subject | P11187 | Unknown | 1500 mg | Oral |