drugset / Trial / NCT02566759
A TAK-831-1001, Single and Multiple Rising Dose Study in Healthy Participants
RandomizedParallel-groupDouble-blindOther
Summary
The purpose of this study is to determine the safety, tolerability and pharmacokinetics (PK) of single and multiple rising doses of TAK-831 in healthy participants.
Timeline
- Start
- 2015-09-23
- Primary completion
- 2016-06-09
- Completion
- 2016-07-12
Outcome
Outcome not reported
Stopped: “The study was terminated by Takeda due to the discomfort observed in the study participants from the CSF collection procedure in Part 3 of the study.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Luvadaxistat | Small molecule | 10 mg | Oral |
| Subject | Luvadaxistat | Small molecule | 30 mg | Oral |
| Subject | Luvadaxistat | Small molecule | 100 mg | Oral |
| Subject | Luvadaxistat | Small molecule | 200 mg | Oral |
| Subject | Luvadaxistat | Small molecule | 250 mg | Oral |
| Subject | Luvadaxistat | Small molecule | 400 mg | Oral |
| Subject | Luvadaxistat | Small molecule | 500 mg | Oral |
| Subject | Luvadaxistat | Small molecule | 750 mg | Oral |
Indications
No indication recorded.