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NCT03919409 · ClinicalTrials.gov registry record · Phase 1
First-in-Human Study With Single and Multiple Doses of TS-161 in Healthy Participants
A Phase 1 study, sponsored by Taisho Pharmaceutical R&D.
- Completed
- Registry status
- Phase 1
- Development phase
- 70
- Enrollment target
NCT03919409: Completed Phase 1 study, sponsored by Taisho Pharmaceutical R&D.
NCT03919409 is a Phase 1 study that has completed, run by Taisho Pharmaceutical R&D. The registered enrollment target is 70 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03919409, a Phase 1 study, has completed, sponsored by Taisho Pharmaceutical R&D.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 70 participants
- Enrollment target
Study 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.
Interventions
- DRUG TS-161
- DRUG TS-161 Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2019-06-03 |
| Est. Completion | 2020-02-11 |
| Phase | Phase 1 |
What the finished NCT03919409 record still lists
NCT03919409 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher).
The record links to 0 conditions, and to 2 interventions - of which TS-161 is the first listed.
NCT03919409 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03919409 about?
NCT03919409 is a clinical study titled "First-in-Human Study With Single and Multiple Doses of TS-161 in Healthy Participants". 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)...
What is the current status of trial NCT03919409?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2019-06-03. Estimated completion is 2020-02-11.
What interventions are being tested in trial NCT03919409?
The interventions under investigation include: TS-161 (DRUG), TS-161 Placebo (DRUG).
Who is sponsoring clinical trial NCT03919409?
This trial is sponsored by Taisho Pharmaceutical R&D, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03919409's enrollment target sits among peer trials
70 749th of 2000 higher than 1,227 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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