Safety, Pharmacokinetic, and Pharmacodynamic Study of TS-142 in Healthy Subjects

A Clinical Pharmacological Study of TS-142 in Non-Elderly and Elderly Healthy Participants (A Repeated-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TS-142 in Elderly and Non-Elderly Participants)

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 and elderly participants

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: Step 1: TS-142; Drug: Step 2: TS-142; Drug: Step 2: Placebo

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Sumida-ku, Tokyo, Japan, 130-0004
      • Sumida Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Body mass index (BMI) ≥18.5 and <25.0 kg/m^2 and body weight is more than 40.0 kg at screening inspection
• Other protocol defined inclusion criteria could apply

Exclusion Criteria:

• History of clinically relevant disease of any organ system that may interfere with the objectives of the study or provide a risk to the health of the participant
• History of drug and food allergy
• Other protocol defined exclusion criteria could apply

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Step 1;TS-142	Drug: Step 1: TS-142; Non-elderly participants will receive 20 mg of TS-142 once daily for 7 consective days
Experimental: Step 2;TS-142	Drug: Step 2: TS-142; Elderly participants will receive 20 mg of TS-142 once daily for 7 consective days; Drug: Step 2: Placebo; Elderly participants will receive placebo once daily for 7 consective days
Placebo Comparator: Step 2;Placebo	Drug: Step 2: TS-142; Elderly participants will receive 20 mg of TS-142 once daily for 7 consective days; Drug: Step 2: Placebo; Elderly participants will receive placebo once daily for 7 consective days

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 14
Area under the concentration-time curve AUC (tau)	Concentration of TS-142 and its metabolites in plasma	Day 1 up to Day 9
Step2; Subjective Alertness via Karolinska Sleepiness Scale (KSS)	Step2; as a measure of subjective alertness which is scored by 10 cm-VAS scale ranging from 1, extremely alert, to 9, extremely sleepy at the next morning after administration.	Day 1 up to Day 8

Collaborators and Investigators

• Sponsor: Taisho Pharmaceutical Co., Ltd.
• Investigators: Study Director: Taisho Director, 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): September 17, 2019
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): November 30, 2019

Study Registration Dates

• First Submitted: September 9, 2019
• First Submitted That Met QC Criteria: September 11, 2019
• First Posted (Actual): September 12, 2019

Study Record Updates

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

More Information

Terms related to this study

• Other Study ID Numbers: TS142-202

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