drugset / Trial / NCT02029482
Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-128800 in Healthy Subjects
RandomizedParallel-groupQuadruple-blind
Summary
This was a single-center, randomized, double-blind, placebo-controlled, up-titration Phase 1 study. Sixteen subjects in two groups (at least 40% of subjects of either male or female sex), with 12 subjects in the active treatment group with an up-titration scheme from 10 to 100 mg, and 4 subjects in the placebo treatment group. Subjects were administered ascending doses of ACT-128800/placebo once daily for 3 days at each dose level: 10 mg, 20 mg, 40 mg, 60 mg, 80 mg, and 100 mg.
Timeline
- Start
- 2010-04
- Primary completion
- 2010-06
- Completion
- 2010-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ponesimod | Small molecule | 10 mg | — |
| Subject | Ponesimod | Small molecule | 20 mg | — |
| Subject | Ponesimod | Small molecule | 40 mg | — |
| Subject | Ponesimod | Small molecule | 60 mg | — |
| Subject | Ponesimod | Small molecule | 80 mg | — |
| Subject | Ponesimod | Small molecule | 100 mg | — |
Indications
No indication recorded.