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

NCT ID: NCT04169893

Last Updated: 2025-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-17

Study Completion Date

2016-02-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Arm Title: Placebo (fasting)

fasting

Group Type PLACEBO_COMPARATOR

Placebo (fasting)

Intervention Type DRUG

Participants will receive placebo once in fasting condition

1 mg of TS-142

Intervention Type DRUG

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

3 mg of TS-142

Intervention Type DRUG

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

10 mg of TS-142 (fasting)

Intervention Type DRUG

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

30 mg of TS-142

Intervention Type DRUG

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

Placebo (feeding)

after meal

Group Type PLACEBO_COMPARATOR

Placebo (feeding)

Intervention Type DRUG

Participants will receive placebo once after meal condition

10 mg of TS-142 (feeding)

Intervention Type DRUG

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

TS-142, 1 mg

fasting

Group Type EXPERIMENTAL

Placebo (fasting)

Intervention Type DRUG

Participants will receive placebo once in fasting condition

3 mg of TS-142

Intervention Type DRUG

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

10 mg of TS-142 (fasting)

Intervention Type DRUG

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

30 mg of TS-142

Intervention Type DRUG

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

TS-142, 3 mg

fasting

Group Type EXPERIMENTAL

1 mg of TS-142

Intervention Type DRUG

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

3 mg of TS-142

Intervention Type DRUG

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

10 mg of TS-142 (fasting)

Intervention Type DRUG

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

30 mg of TS-142

Intervention Type DRUG

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

TS-142, 10 mg (fasting)

fasting

Group Type EXPERIMENTAL

Placebo (fasting)

Intervention Type DRUG

Participants will receive placebo once in fasting condition

1 mg of TS-142

Intervention Type DRUG

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

3 mg of TS-142

Intervention Type DRUG

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

10 mg of TS-142 (fasting)

Intervention Type DRUG

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

10 mg of TS-142 (feeding)

Intervention Type DRUG

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

30 mg of TS-142

Intervention Type DRUG

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

TS-142, 10 mg (feeding)

after meal

Group Type EXPERIMENTAL

Placebo (feeding)

Intervention Type DRUG

Participants will receive placebo once after meal condition

10 mg of TS-142 (fasting)

Intervention Type DRUG

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

10 mg of TS-142 (feeding)

Intervention Type DRUG

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

TS-142, 30 mg

fasting

Group Type EXPERIMENTAL

Placebo (fasting)

Intervention Type DRUG

Participants will receive placebo once in fasting condition

1 mg of TS-142

Intervention Type DRUG

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

3 mg of TS-142

Intervention Type DRUG

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

10 mg of TS-142 (fasting)

Intervention Type DRUG

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

30 mg of TS-142

Intervention Type DRUG

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

Interventions

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Placebo (fasting)

Participants will receive placebo once in fasting condition

Intervention Type DRUG

Placebo (feeding)

Participants will receive placebo once after meal condition

Intervention Type DRUG

1 mg of TS-142

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

Intervention Type DRUG

3 mg of TS-142

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

Intervention Type DRUG

10 mg of TS-142 (fasting)

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

Intervention Type DRUG

10 mg of TS-142 (feeding)

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

Intervention Type DRUG

30 mg of TS-142

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

39 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Taisho Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shigeru Okuyama

Role: STUDY_DIRECTOR

Taisho Pharmaceutical Co., Ltd.

Locations

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The medical facility selected by Taisho Pharmaceutical Co., Ltd

Fukuoka, , Japan

Site Status

Countries

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Japan

References

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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.

Reference Type BACKGROUND
PMID: 37563858 (View on PubMed)

Other Identifiers

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TS142-101

Identifier Type: -

Identifier Source: org_study_id

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