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drugset / Trial / NCT03919409

First-in-Human Study With Single and Multiple Doses of TS-161 in Healthy Participants

NCT03919409 ↗

Phase 1 Completed 70 enrolled Taisho Pharmaceutical R&D Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a Phase 1, first-in-human study involving single and multiple oral doses of TS-161 in healthy male and female participants. The safety, tolerability, pharmacokinetics and pharmacodynamics of TS-161 will be evaluated. The study includes 3 parts; Part A (single ascending dose: Cohorts 1 to 5) , Part B (single dose, cerebrospinal fluid \[CSF\] collection: Cohort 6), and Part C (multiple ascending dose: Cohorts 7 to 9). Participants will be assigned to one of the 9 Cohorts.

Timeline

Start
2019-06-03
Primary completion
2020-02-11
Completion
2020-02-11

Drugs

EvaluationDrugModalityDoseRoute
Subject TS-161 Unknown 15 mg Oral
Subject TS-161 Unknown 50 mg Oral
Subject TS-161 Unknown 100 mg Oral
Subject TS-161 Unknown 200 mg Oral
Subject TS-161 Unknown 400 mg Oral

Indications

No indication recorded.