CompletedNCT04087707Updated Feb 28, 2025

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

A Phase 2 interventional study of Step 1: TS-142 and Step 2: TS-142 in Healthy Volunteer, sponsored by Taisho Pharmaceutical Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-28.

Sponsored by Taisho Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 23
Allocation: Randomized
Ages: 20 Years and older
Sex: All

Study 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 and elderly participants

Conditions studied

Healthy Volunteer

In context

Lead sponsor

Taisho Pharmaceutical Co., Ltd. is the lead sponsor of 43 studies on the registry; 4 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 23 participants (actual)

Study arms

Experimental
Step 1;TS-142
Drug: Step 1: TS-142
Experimental
Step 2;TS-142
Drug: Step 2: TS-142 · Drug: Step 2: Placebo
Placebo comparator
Step 2;Placebo
Drug: Step 2: TS-142 · Drug: Step 2: Placebo

Interventions

DrugStep 1: TS-142
Non-elderly participants will receive 20 mg of TS-142 once daily for 7 consective days
DrugStep 2: TS-142
Elderly participants will receive 20 mg of TS-142 once daily for 7 consective days
DrugStep 2: Placebo
Elderly participants will receive placebo once daily for 7 consective days

What researchers measure

Primary outcomes

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
Time frame: Day 1 up to Day 14
Area under the concentration-time curve AUC (tau)
Concentration of TS-142 and its metabolites in plasma
Time frame: 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.
Time frame: Day 1 up to Day 8

Study locations

1 site

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

References and documents

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. PubMed 37563858 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04087707
Lead sponsor: Taisho Pharmaceutical Co., Ltd.
Responsible party: Sponsor
First posted: Sep 12, 2019
Start date: Sep 17, 2019
Primary completion: Nov 30, 2019
Completion: Nov 30, 2019
Last update: Feb 28, 2025

Study contacts

Taisho Director

study director · Taisho Pharmaceutical Co., Ltd.

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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