Healthy VolunteerPhase 1NCT04169893
A Phase I Study of TS-142 in Healthy Participants (Single Doses)
A Phase 1 study testing 1 mg of TS-142, 3 mg of TS-142 and 10 mg of TS-142 (fasting) in people with Healthy Volunteer, run by Taisho Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 39 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- 1 mg of TS-142, 3 mg of TS-142 and 10 mg of TS-142 (fasting)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteJapan
- Study dates
- 17 Oct 2015to 6 Feb 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 39 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) ≥18.5 and <25.0 kg/m^2 at screening inspection
Who cannot join
- History of clinically relevant disease of some organ systems that may be considerd inappropriately for this study
- History of drug and food allergy
Trial locations and contacts
1 site in 1 country.
Japan1 site
The medical facility selected by Taisho Pharmaceutical Co., Ltd
Fukuoka
About this study
Official title: A Phase I Study of TS-142 in Non-Elderly Healthy Participants (Single Doses) (A Single Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TS-142 in Non-Elderly Participants)
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.
- Conditions
- Healthy Volunteer
- Being tested
- Placebo (fasting), Placebo (feeding), 1 mg of TS-142, 3 mg of TS-142, 10 mg of TS-142 (fasting)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo (fasting)Drug
Participants will receive placebo once in fasting condition
Placebo (feeding)Drug
Participants will receive placebo once after meal condition
1 mg of TS-142Drug
Participants will receive 1 mg of TS-142 once in fasting condition
3 mg of TS-142Drug
Participants will receive 3 mg of TS-142 once in fasting condition
10 mg of TS-142 (fasting)Drug
Participants will receive 10 mg of TS-142 once in fasting condition
10 mg of TS-142 (feeding)Drug
Participants will receive 10 mg of TS-142 once after meal condition
30 mg of TS-142Drug
Participants will receive 30 mg of TS-142 once in fasting condition
| Study group | Role | What they receive |
|---|---|---|
| Arm Title: Placebo (fasting) | Placebo comparator | fasting Receives: 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 (feeding) | Placebo comparator | after meal Receives: Drug: Placebo (feeding); Drug: 10 mg of TS-142 (feeding) |
| TS-142, 1 mg | Experimental | fasting Receives: Drug: Placebo (fasting); Drug: 3 mg of TS-142; Drug: 10 mg of TS-142 (fasting); Drug: 30 mg of TS-142 |
| TS-142, 3 mg | Experimental | fasting Receives: 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 |
| TS-142, 10 mg (fasting) | Experimental | fasting Receives: 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 |
| TS-142, 10 mg (feeding) | Experimental | after meal Receives: Drug: Placebo (feeding); Drug: 10 mg of TS-142 (fasting); Drug: 10 mg of TS-142 (feeding) |
| TS-142, 30 mg | Experimental | fasting Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1 up to Day 8
Area under the concentration-time curve AUC (tau)
Concentration of TS-142 and its metabolites in plasma
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start17 Oct 2015
- Primary completion6 Feb 2016
- Study completion6 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shigeru Okuyama, Study director, Taisho Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04169893
- Sponsor's protocol ID
- TS142-101
- Status last verified
- Nov 2019
- First submitted
- 18 Nov 2019
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of TS-142 in Non-Elderly Healthy Participants (Single Doses) (A Single Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TS-142 in Non-Elderly Participants)
- ClinicalTrials.gov ID
- NCT04169893
- Acronym / sponsor ID
- TS142-101
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Oct 2015 (actual)
- Primary completion
- 6 Feb 2016 (actual)
- Study completion
- 6 Feb 2016 (actual)
- First posted
- 20 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Arm Title: Placebo (fasting) | Placebo comparator | 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-142fasting |
| Placebo (feeding) | Placebo comparator | Drug: Placebo (feeding), Drug: 10 mg of TS-142 (feeding)after meal |
| TS-142, 1 mg | Experimental | Drug: Placebo (fasting), Drug: 3 mg of TS-142, Drug: 10 mg of TS-142 (fasting), Drug: 30 mg of TS-142fasting |
| TS-142, 3 mg | Experimental | Drug: 1 mg of TS-142, Drug: 3 mg of TS-142, Drug: 10 mg of TS-142 (fasting), Drug: 30 mg of TS-142fasting |
| TS-142, 10 mg (fasting) | Experimental | 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-142fasting |
| TS-142, 10 mg (feeding) | Experimental | Drug: Placebo (feeding), Drug: 10 mg of TS-142 (fasting), Drug: 10 mg of TS-142 (feeding)after meal |
| TS-142, 30 mg | Experimental | 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-142fasting |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body mass index (BMI) ≥18.5 and <25.0 kg/m^2 at screening inspection
Key exclusion criteria (2 listed)
- History of clinically relevant disease of some organ systems that may be considerd inappropriately for this study
- History of drug and food allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo (fasting)Participants will receive placebo once in fasting condition | Drug | Arm Title: Placebo (fasting), TS-142, 1 mg, TS-142, 10 mg (fasting), TS-142, 30 mg |
| Placebo (feeding)Participants will receive placebo once after meal condition | Drug | Placebo (feeding), TS-142, 10 mg (feeding) |
| 1 mg of TS-142Participants will receive 1 mg of TS-142 once in fasting condition | Drug | Arm Title: Placebo (fasting), TS-142, 10 mg (fasting), TS-142, 3 mg, TS-142, 30 mg |
| 3 mg of TS-142Participants will receive 3 mg of TS-142 once in fasting condition | Drug | Arm Title: Placebo (fasting), TS-142, 1 mg, TS-142, 10 mg (fasting), TS-142, 3 mg, TS-142, 30 mg |
| 10 mg of TS-142 (fasting)Participants will receive 10 mg of TS-142 once in fasting condition | Drug | Arm Title: Placebo (fasting), TS-142, 1 mg, TS-142, 10 mg (fasting), TS-142, 10 mg (feeding), TS-142, 3 mg, TS-142, 30 mg |
| 10 mg of TS-142 (feeding)Participants will receive 10 mg of TS-142 once after meal condition | Drug | Placebo (feeding), TS-142, 10 mg (fasting), TS-142, 10 mg (feeding) |
| 30 mg of TS-142Participants will receive 30 mg of TS-142 once in fasting condition | Drug | Arm Title: Placebo (fasting), TS-142, 1 mg, TS-142, 10 mg (fasting), TS-142, 3 mg, TS-142, 30 mg |
Primary outcome
Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs)
Time frame: Day 1 up to Day 8
Number of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) reported as mild, moderate, severe
Area under the concentration-time curve AUC (tau)
Time frame: 48 hours
Concentration of TS-142 and its metabolites in plasma
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Results publication: PubMed 37563858Kambe 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shigeru Okuyama study director
Taisho Pharmaceutical Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 1 mg of TS-142, 3 mg of TS-142 and 10 mg of TS-142 (fasting) in people with Healthy Volunteer, run by Taisho Pharmaceutical Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) (time frame: Day 1 up to Day 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04169893, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.