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Safety, Tolerability and Pharmacokinetics of 14-day Multiple Dose Titrations of TS-134 in Healthy Volunteers

NCT03742791 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2018-11-15

No results posted yet for this study

Summary

This is a Phase 1 study involving multiple dose titrations of TS-134 in healthy male and female subjects. The safety, tolerability and pharmacokinetics of multiple dose titrations of TS-134 will be evaluated.

Conditions

  • Healthy Volunteers

Interventions

DRUG

TS-134

5 mg to 80 mg oral solution

DRUG

Placebo

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
2016-06-28
Primary Completion
2016-12-12
Completion
2016-12-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03742791 on ClinicalTrials.gov