A Phase I Study of TS-142 in Healthy Participants (Repeated Doses)

NCT04169906 | Completed Phase 1

• 1 other identifier: TS142-102
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the safety, pharmacokinetics, and pharmacodynamics of repeated dosing of TS-142 when administered once daily to healthy Japanese non-elderly participants.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs)

  Number of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) reported as mild, moderate, severe

  Day 1 up to Day 14

• Area under the concentration-time curve AUC (tau)

  Concentration of TS-142 and its metabolites in plasma

  Day 1 up to Day 9

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Drug: Placebo; Drug: TS-142, 10 mg; Drug: TS-142, 20 mg; Drug: TS-142, 30 mg

TS-142 10 mg

EXPERIMENTAL

Drug: Placebo; Drug: TS-142, 10 mg; Drug: TS-142, 20 mg; Drug: TS-142, 30 mg

TS-142 20 mg

EXPERIMENTAL

Drug: Placebo; Drug: TS-142, 10 mg; Drug: TS-142, 20 mg; Drug: TS-142, 30 mg

TS-142 30 mg

EXPERIMENTAL

Drug: Placebo; Drug: TS-142, 10 mg; Drug: TS-142, 20 mg; Drug: TS-142, 30 mg

Interventions

Placebo DRUG

Participants will receive placebo once daily for 7 consective days

Placebo; TS-142 10 mg; TS-142 20 mg; TS-142 30 mg

TS-142, 10 mg DRUG

Participants will receive 10 mg of TS-142 once daily for 7 consective days

Placebo; TS-142 10 mg; TS-142 20 mg; TS-142 30 mg

TS-142, 20 mg DRUG

Participants will receive 20 mg of TS-142 once daily for 7 consective days

Placebo; TS-142 10 mg; TS-142 20 mg; TS-142 30 mg

TS-142, 30 mg DRUG

Participants will receive 30 mg of TS-142 once daily for 7 consective days

Placebo; TS-142 10 mg; TS-142 20 mg; TS-142 30 mg

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index (BMI) ≥18.5 and \<25.0 kg/m\^2 at screening inspection

You may not qualify if:

• History of clinically relevant disease of some organ systems that may be considerd inappropriately for this study
• History of drug and food allergy

Sponsors & Collaborators

• Taisho Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The medical facility selected by Taisho Pharmaceutical Co., Ltd

Fukuoka, Japan

Location

Related Publications (1)

• Kambe D, Hasegawa S, Imadera Y, Mano Y, Matsushita I, Konno Y, Ogo H, Uchimura N, Uchiyama M. Pharmacokinetics, pharmacodynamics and safety profile of the dual orexin receptor antagonist vornorexant/TS-142 in healthy Japanese participants following single/multiple dosing: Randomized, double-blind, placebo-controlled phase-1 studies. Basic Clin Pharmacol Toxicol. 2023 Nov;133(5):576-591. doi: 10.1111/bcpt.13930. Epub 2023 Sep 10.

  PMID: 37563858 BACKGROUND

MeSH Terms

Interventions

TS-142

Study Officials

• Shigeru Okuyama

  Taisho Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 20, 2019
• Study Start: July 6, 2016
• Primary Completion: October 8, 2016
• Study Completion: October 8, 2016
• Last Updated: February 28, 2025

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)