drugset / Trial / NCT02420782
First-in-human: Single Ascending Dose, Food Effect, Drug-drug Interaction, Multiple Ascending Dose, Proof of Pharmacology
RandomizedParallel-groupDouble-blindBasic science
Summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending oral doses of ASP6282 in healthy male and female subjects. 1 cohort (elderly) receives also a midazolam dosing. This study will also explore the effect of itraconazole (another drug) on the PK of ASP6282, as well as to evaluate the safety and tolerability of ASP6282 alone and in combination with itraconazole in healthy male and female subjects. Also, this study is to evaluate the PD and PK effects of single oral doses of ASP6282 on pilocarpine-induced salivation and pupil diameter in healthy nonelderly male and female subjects.
Timeline
- Start
- 2015-05
- Primary completion
- 2016-05
- Completion
- 2016-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ASP6282 | Unknown | — | Oral |
| Subject | Itraconazole | Small molecule | — | Oral |
| Subject | Midazolam | Small molecule | — | Oral |
| Background | Pilocarpine | Unknown | — | Oral |
Indications
No indication recorded.