A Phase I Study of TS-142 in Healthy Participants (Repeated Doses)
NCT ID: NCT04169906
Last Updated: 2025-02-28
Study Results
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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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2016-07-06
2016-10-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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Placebo
Placebo
Participants will receive placebo once daily for 7 consective days
TS-142, 10 mg
Participants will receive 10 mg of TS-142 once daily for 7 consective days
TS-142, 20 mg
Participants will receive 20 mg of TS-142 once daily for 7 consective days
TS-142, 30 mg
Participants will receive 30 mg of TS-142 once daily for 7 consective days
TS-142 10 mg
Placebo
Participants will receive placebo once daily for 7 consective days
TS-142, 10 mg
Participants will receive 10 mg of TS-142 once daily for 7 consective days
TS-142, 20 mg
Participants will receive 20 mg of TS-142 once daily for 7 consective days
TS-142, 30 mg
Participants will receive 30 mg of TS-142 once daily for 7 consective days
TS-142 20 mg
Placebo
Participants will receive placebo once daily for 7 consective days
TS-142, 10 mg
Participants will receive 10 mg of TS-142 once daily for 7 consective days
TS-142, 20 mg
Participants will receive 20 mg of TS-142 once daily for 7 consective days
TS-142, 30 mg
Participants will receive 30 mg of TS-142 once daily for 7 consective days
TS-142 30 mg
Placebo
Participants will receive placebo once daily for 7 consective days
TS-142, 10 mg
Participants will receive 10 mg of TS-142 once daily for 7 consective days
TS-142, 20 mg
Participants will receive 20 mg of TS-142 once daily for 7 consective days
TS-142, 30 mg
Participants will receive 30 mg of TS-142 once daily for 7 consective days
Interventions
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Placebo
Participants will receive placebo once daily for 7 consective days
TS-142, 10 mg
Participants will receive 10 mg of TS-142 once daily for 7 consective days
TS-142, 20 mg
Participants will receive 20 mg of TS-142 once daily for 7 consective days
TS-142, 30 mg
Participants will receive 30 mg of TS-142 once daily for 7 consective days
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of drug and food allergy
20 Years
39 Years
MALE
Yes
Sponsors
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Taisho Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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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
Countries
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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.
Other Identifiers
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TS142-102
Identifier Type: -
Identifier Source: org_study_id
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