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CompletedNCT04169893Updated Feb 28, 2025

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

A Phase 1 interventional study of Placebo (fasting) and Placebo (feeding) in Healthy Volunteer, sponsored by Taisho Pharmaceutical Co., Ltd.. Completed at 1 site in Japan. Open to male participants aged 20 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-28.

Sponsored by Taisho Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 1 month after the study started (first participant enrolled Oct 2015, registered Nov 2019).
Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
20 Years to 39 Years
Sex
Male
01

Study summary

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.

02

Conditions studied

  • Healthy Volunteer
03

In context

Lead sponsor

Taisho Pharmaceutical Co., Ltd. is the lead sponsor of 41 studies on the registry; 4 are open to participants now.

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

04

Who can participate

Ages eligible
20 Years to 39 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
32 participants (actual)

Study arms

  • Placebo comparator
    Arm Title: Placebo (fasting)

    fasting

    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

  • Placebo comparator
    Placebo (feeding)

    after meal

    Drug: Placebo (feeding) · Drug: 10 mg of TS-142 (feeding)

  • Experimental
    TS-142, 1 mg

    fasting

    Drug: Placebo (fasting) · Drug: 3 mg of TS-142 · Drug: 10 mg of TS-142 (fasting) · Drug: 30 mg of TS-142

  • Experimental
    TS-142, 3 mg

    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

  • Experimental
    TS-142, 10 mg (fasting)

    fasting

    Drug: Placebo (fasting) · Drug: 1 mg of TS-142 · Drug: 3 mg of TS-142 · Drug: 10 mg of TS-142 (fasting) · Drug: 10 mg of TS-142 (feeding) · Drug: 30 mg of TS-142

  • Experimental
    TS-142, 10 mg (feeding)

    after meal

    Drug: Placebo (feeding) · Drug: 10 mg of TS-142 (fasting) · Drug: 10 mg of TS-142 (feeding)

  • Experimental
    TS-142, 30 mg

    fasting

    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

Interventions

  • DrugPlacebo (fasting)

    Participants will receive placebo once in fasting condition

  • DrugPlacebo (feeding)

    Participants will receive placebo once after meal condition

  • Drug1 mg of TS-142

    Participants will receive 1 mg of TS-142 once in fasting condition

  • Drug3 mg of TS-142

    Participants will receive 3 mg of TS-142 once in fasting condition

  • Drug10 mg of TS-142 (fasting)

    Participants will receive 10 mg of TS-142 once in fasting condition

  • Drug10 mg of TS-142 (feeding)

    Participants will receive 10 mg of TS-142 once after meal condition

  • Drug30 mg of TS-142

    Participants will receive 30 mg of TS-142 once in fasting condition

06

What researchers measure

Primary outcomes

  1. 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 8

  2. Area under the concentration-time curve AUC (tau)

    Concentration of TS-142 and its metabolites in plasma

    Time frame: 48 hours

07

Study locations

1 site
  • The medical facility selected by Taisho Pharmaceutical Co., Ltd
    Fukuoka, Japan
08

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

09

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 ↗
10

Registry details

Key details

Study ID
NCT04169893
Lead sponsor
Taisho Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Nov 20, 2019
Start date
Oct 17, 2015
Primary completion
Feb 6, 2016
Completion
Feb 6, 2016
Last update
Feb 28, 2025

Study contacts

Shigeru Okuyama
study director · Taisho Pharmaceutical Co., Ltd.

Oversight

Data monitoring committee
No
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 Nov 2019. You cannot join it, but the record below documents what was studied.

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