drugset / Trial / NCT02419820
Dose-escalation, Repeated and Single Oral Dosing Study
RandomizedParallel-groupQuadruple-blindScreening
Summary
Randomized, Double-blind, Placebo-controlled, Dose-escalation, Repeated and Single Oral Dosing Phase I Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety of APD791 (Temanogrel) Co-administered with Aspirin and Clopidogrel.
Timeline
- Start
- 2015-03
- Primary completion
- 2016-04
- Completion
- 2016-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Temanogrel | Small molecule | 2 mg | Oral |
| Subject | Temanogrel | Small molecule | 5 mg | Oral |
| Subject | Temanogrel | Small molecule | 10 mg | Oral |
| Subject | Temanogrel | Small molecule | 20 mg | Oral |
| Subject | Temanogrel | Small molecule | 40 mg | Oral |
| Subject | Temanogrel | Small molecule | 80 mg | Oral |
| Subject | Temanogrel | Small molecule | 160 mg | Oral |
| Subject | Temanogrel | Small molecule | 240 mg | Oral |
| Subject | Temanogrel | Small molecule | 320 mg | Oral |
| Background | Aspirin | Small molecule | — | Oral |
| Background | Clopidogrel | Small molecule | — | Oral |