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

A Phase I Study of TS-142 in Non-Elderly Healthy Participants (Single Doses) (A Single Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TS-142 in Non-Elderly Participants)

The purpose of this study is to investigate the safety and pharmacokinetics of single dosing of TS-142 to healthy Japanese non-elderly participants in fasting and after meal condition.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: Placebo (fasting); Drug: 1 mg of TS-142; Drug: 3 mg of TS-142; Drug: 10 mg of TS-142 (fasting); Drug: 30 mg of TS-142; Drug: Placebo (feeding); Drug: 10 mg of TS-142 (feeding)

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan
    • The medical facility selected by Taisho Pharmaceutical Co., Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 39 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Arm Title: Placebo (fasting); fasting	Drug: Placebo (fasting); Participants will receive placebo once in fasting condition; Drug: 1 mg of TS-142; Participants will receive 1 mg of TS-142 once in fasting condition; Drug: 3 mg of TS-142; Participants will receive 3 mg of TS-142 once in fasting condition; Drug: 10 mg of TS-142 (fasting); Participants will receive 10 mg of TS-142 once in fasting condition; Drug: 30 mg of TS-142; Participants will receive 30 mg of TS-142 once in fasting condition
Placebo Comparator: Placebo (feeding); after meal	Drug: Placebo (feeding); Participants will receive placebo once after meal condition; Drug: 10 mg of TS-142 (feeding); Participants will receive 10 mg of TS-142 once after meal condition
Experimental: TS-142, 1 mg; fasting	Drug: Placebo (fasting); Participants will receive placebo once in fasting condition; Drug: 3 mg of TS-142; Participants will receive 3 mg of TS-142 once in fasting condition; Drug: 10 mg of TS-142 (fasting); Participants will receive 10 mg of TS-142 once in fasting condition; Drug: 30 mg of TS-142; Participants will receive 30 mg of TS-142 once in fasting condition
Experimental: TS-142, 3 mg; fasting	Drug: 1 mg of TS-142; Participants will receive 1 mg of TS-142 once in fasting condition; Drug: 3 mg of TS-142; Participants will receive 3 mg of TS-142 once in fasting condition; Drug: 10 mg of TS-142 (fasting); Participants will receive 10 mg of TS-142 once in fasting condition; Drug: 30 mg of TS-142; Participants will receive 30 mg of TS-142 once in fasting condition
Experimental: TS-142, 10 mg (fasting); fasting	Drug: Placebo (fasting); Participants will receive placebo once in fasting condition; Drug: 1 mg of TS-142; Participants will receive 1 mg of TS-142 once in fasting condition; Drug: 3 mg of TS-142; Participants will receive 3 mg of TS-142 once in fasting condition; Drug: 10 mg of TS-142 (fasting); Participants will receive 10 mg of TS-142 once in fasting condition; Drug: 30 mg of TS-142; Participants will receive 30 mg of TS-142 once in fasting condition; Drug: 10 mg of TS-142 (feeding); Participants will receive 10 mg of TS-142 once after meal condition
Experimental: TS-142, 10 mg (feeding); after meal	Drug: 10 mg of TS-142 (fasting); Participants will receive 10 mg of TS-142 once in fasting condition; Drug: Placebo (feeding); Participants will receive placebo once after meal condition; Drug: 10 mg of TS-142 (feeding); Participants will receive 10 mg of TS-142 once after meal condition
Experimental: TS-142, 30 mg; fasting	Drug: Placebo (fasting); Participants will receive placebo once in fasting condition; Drug: 1 mg of TS-142; Participants will receive 1 mg of TS-142 once in fasting condition; Drug: 3 mg of TS-142; Participants will receive 3 mg of TS-142 once in fasting condition; Drug: 10 mg of TS-142 (fasting); Participants will receive 10 mg of TS-142 once in fasting condition; Drug: 30 mg of TS-142; Participants will receive 30 mg of TS-142 once in fasting condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 8
Area under the concentration-time curve AUC (tau)	Concentration of TS-142 and its metabolites in plasma	48 hours

Collaborators and Investigators

• Sponsor: Taisho Pharmaceutical Co., Ltd.
• Investigators: Study Director: Shigeru Okuyama, Taisho Pharmaceutical Co., Ltd.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2015
• Primary Completion (Actual): February 6, 2016
• Study Completion (Actual): February 6, 2016

Study Registration Dates

• First Submitted: November 18, 2019
• First Submitted That Met QC Criteria: November 18, 2019
• First Posted (Actual): November 20, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 26, 2025
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: TS142-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No