MedTrace Logo

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

NCT03919409 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2020-02-28

No results posted yet for this 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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

TS-161

TS-161 capsules

DRUG

TS-161 Placebo

TS-161 matching placebo capsules

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
2019-06-03
Primary Completion
2020-02-11
Completion
2020-02-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03919409 on ClinicalTrials.gov