NCT04169893

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 17, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2016

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2019

Completed
Last Updated

February 28, 2025

Status Verified

November 1, 2019

Enrollment Period

4 months

First QC Date

November 18, 2019

Last Update Submit

February 26, 2025

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 8

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

    Concentration of TS-142 and its metabolites in plasma

    48 hours

Study Arms (7)

Arm Title: Placebo (fasting)

PLACEBO COMPARATOR

fasting

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

Placebo (feeding)

PLACEBO COMPARATOR

after meal

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

TS-142, 1 mg

EXPERIMENTAL

fasting

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

TS-142, 3 mg

EXPERIMENTAL

fasting

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

TS-142, 10 mg (fasting)

EXPERIMENTAL

fasting

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

TS-142, 10 mg (feeding)

EXPERIMENTAL

after meal

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

TS-142, 30 mg

EXPERIMENTAL

fasting

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

Interventions

Placebo (fasting)DRUG

Participants will receive placebo once in fasting condition

Arm Title: Placebo (fasting)TS-142, 1 mgTS-142, 10 mg (fasting)TS-142, 30 mg
Placebo (feeding)DRUG

Participants will receive placebo once after meal condition

Placebo (feeding)TS-142, 10 mg (feeding)
1 mg of TS-142DRUG

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

Arm Title: Placebo (fasting)TS-142, 10 mg (fasting)TS-142, 3 mgTS-142, 30 mg
3 mg of TS-142DRUG

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

Arm Title: Placebo (fasting)TS-142, 1 mgTS-142, 10 mg (fasting)TS-142, 3 mgTS-142, 30 mg
10 mg of TS-142 (fasting)DRUG

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

Arm Title: Placebo (fasting)TS-142, 1 mgTS-142, 10 mg (fasting)TS-142, 10 mg (feeding)TS-142, 3 mgTS-142, 30 mg
10 mg of TS-142 (feeding)DRUG

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

Placebo (feeding)TS-142, 10 mg (fasting)TS-142, 10 mg (feeding)
30 mg of TS-142DRUG

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

Arm Title: Placebo (fasting)TS-142, 1 mgTS-142, 10 mg (fasting)TS-142, 3 mgTS-142, 30 mg

Eligibility Criteria

Age20 Years - 39 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 37563858BACKGROUND

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

October 17, 2015

Primary Completion

February 6, 2016

Study Completion

February 6, 2016

Last Updated

February 28, 2025

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)