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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. 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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03919409
The ClinicalTrials.gov registry entry for NCT03919409 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Taisho Pharmaceutical R&D, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which TS-161 is the first listed.
NCT03919409 reports 0 study locations.
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.
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