A Single Ascending and Repeated Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TS-142 in Healthy Participants

ClinicalTrials.gov ID: NCT04464239

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Official title

A Randomized, Double-blind, Placebo-controlled, Single Ascending and Repeated Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TS-142 Administered Orally to Healthy Male and Female Participants

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a study to evaluate the safety, tolerability, and pharmacokinetics of single oral doses of TS-142 compared to placebo and of a single repeated dose compared to placebo in healthy volunteers. This Phase I study is composed of two parts; Part A (Single Ascending Dose) and Part B (Repeated Dose). The study employs a randomized, double-blind, placebo-controlled, parallel group design to evaluate the single and repeat-dose safety and pharmacokinetics of TS-142 in healthy participants.

Study identification

NCT ID: NCT04464239
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Taisho Pharmaceutical R&D Inc.; Industry
Enrollment: 28 participants

Conditions and interventions

Conditions

Healthy Volunteers

Interventions

TS-142 Drug
TS-142 Placebo Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 55 Years
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 14, 2020 (Actual)
Primary completion: Jan 21, 2021 (Actual)
Completion: Jan 21, 2021 (Actual)
Last update posted: Feb 10, 2021

2020 – 2021

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
PPD Phase I unit	Austin	Texas	78744	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04464239, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Feb 10, 2021 · Synced Nov 14, 2026