Safety, Tolerability and Pharmacokinetics of Single Doses of TS-134 in Healthy Volunteers
NCT03746067 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33
Last updated 2018-11-19
Summary
This is a Phase 1a study involving single oral dose of TS-134 in healthy male and female subjects. The safety, tolerability and pharmacokinetics of single dose of TS-134 will be evaluated.
Conditions
- Healthy Volunteers
Interventions
- DRUG
-
TS-134
5 mg, 10 mg, or 20 mg oral solution
- DRUG
-
Matched Placebo oral solution
Sponsors & Collaborators
-
Taisho Pharmaceutical R&D Inc.
lead INDUSTRY
Principal Investigators
-
Taisho Director · Taisho Pharmaceutical R&D Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-08-21
- Primary Completion
- 2016-01-13
- Completion
- 2016-01-13
- FDA Drug
- Yes
Countries
- United States
Study Locations
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