Effect of FoodPhase 1NCT05707897
A Food Effect Study of TS-142 in Healthy Subjects
A Phase 1 study testing TS-142 10 mg in people with Effect of Food, run by Taisho Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
This is a study to assess the food effect of TS-142 preliminary market formulation tablet in healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 39 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Effect of Food
- What is being tested?
- TS-142 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteJapan
- Study dates
- 15 Feb 2023to 20 Mar 2023
- 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 18 to 39 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Japanese male who are aged 18 years or older but less than 40 years at the time of informed consent
- Body Mass Index (BMI) of 18.5 or more and less than 25.0 at the screening test
- Subjects who are judged by the investigators as an eligible for the clinical trial participation based on the screening tests and the tests conducted at treatment period 1.
- Other protocol defined inclusion criteria could apply.
Who cannot join
- Subjects who are judged to have any disease by the principal investigator or sub-investigator and are not considered healthy
- Subjects who have any unsuitable medical history for participation in this study, including respiratory, cardiovascular, gastrointestinal, hepatic, renal, urological, endocrinological, metabolic, hematologic, immunologic, dermatological, neurological, or psychiatric diseases
- Subjects who have any medical histories including sleep-associated symptoms, narcolepsy-like symptoms, suicidal ideation, or suicidal attempts
- Other protocol defined exclusion criteria could apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Assess the Food Effect of TS-142 in Healthy Subjects
This is a study to assess the food effect of TS-142 preliminary market formulation tablet in healthy subjects
- Conditions
- Effect of Food
- Being tested
- TS-142 10 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TS-142 10 mgDrug
Single-dose of 10 mg of TS-142
| Study group | Role | What they receive |
|---|---|---|
| Fed condition | Experimental | Period in which subjects receive a single oral dose of TS-142 tablet in fed condition. Receives: Drug: TS-142 10 mg |
| Fasted condition | Experimental | Period in which subjects receive a single oral dose of TS-142 tablet in fasted condition. Receives: Drug: TS-142 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration
Plasma concentration of unchanged form and its metabolite
Measured: Predose and up to 24 hours postdose
Pharmacokinetic parameters
Maximum plasma concentration of unchanged form and its metabolite (Cmax)
Measured: Predose and up to 24 hours postdose
Pharmacokinetic parameters
Time to maximum plasma concentration of unchanged form and its metabolite (tmax)
Measured: Predose and up to 24 hours postdose
Pharmacokinetic parameters
Area under the plasma concentration-time curve extrapolated to infinity of unchanged form and its metabolite (AUCinf)
Measured: Predose and up to 24 hours postdose
Pharmacokinetic parameters
Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration of unchanged form and its metabolite (AUC0-last)
Measured: Predose and up to 24 hours postdose
Pharmacokinetic parameters
Terminal elimination rate constant of unchanged form and its metabolite (λz)
Measured: Predose and up to 24 hours postdose
Pharmacokinetic parameters
Elimination half-life of unchanged form and its metabolite (t1/2)
Measured: Predose and up to 24 hours postdose
Pharmacokinetic parameters
Apparent volume of distribution based on the terminal phase of unchanged form (Vz/F)
Measured: Predose and up to 24 hours postdose
Pharmacokinetic parameters
Apparent total body clearance of unchanged form (CL/F)
Measured: Predose and up to 24 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start15 Feb 2023
- Primary completion20 Mar 2023
- Study completion20 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of FoodStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Taisho Director, Study director, Taisho Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05707897
- Sponsor's protocol ID
- TS142-304
- Status last verified
- Jan 2023
- First submitted
- 22 Jan 2023
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 Study to Assess the Food Effect of TS-142 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05707897
- Acronym / sponsor ID
- TS142-304
- Conditions
- Effect of Food
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 20 Mar 2023 (actual)
- First posted
- 1 Feb 2023 (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.
This is a study to assess the food effect of TS-142 preliminary market formulation tablet in healthy subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fed condition | Experimental | Drug: TS-142 10 mgPeriod in which subjects receive a single oral dose of TS-142 tablet in fed condition. |
| Fasted condition | Experimental | Drug: TS-142 10 mgPeriod in which subjects receive a single oral dose of TS-142 tablet in fasted condition. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Japanese male who are aged 18 years or older but less than 40 years at the time of informed consent
- Body Mass Index (BMI) of 18.5 or more and less than 25.0 at the screening test
- Subjects who are judged by the investigators as an eligible for the clinical trial participation based on the screening tests and the tests conducted at treatment period 1.
- Other protocol defined inclusion criteria could apply.
Key exclusion criteria (4 listed)
- Subjects who are judged to have any disease by the principal investigator or sub-investigator and are not considered healthy
- Subjects who have any unsuitable medical history for participation in this study, including respiratory, cardiovascular, gastrointestinal, hepatic, renal, urological, endocrinological, metabolic, hematologic, immunologic, dermatological, neurological, or psychiatric diseases
- Subjects who have any medical histories including sleep-associated symptoms, narcolepsy-like symptoms, suicidal ideation, or suicidal attempts
- Other protocol defined exclusion criteria could apply.
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 |
|---|---|---|
| TS-142 10 mgSingle-dose of 10 mg of TS-142 | Drug | Fasted condition, Fed condition |
Primary outcome
Plasma concentration
Time frame: Predose and up to 24 hours postdose
Plasma concentration of unchanged form and its metabolite
Pharmacokinetic parameters
Time frame: Predose and up to 24 hours postdose
Maximum plasma concentration of unchanged form and its metabolite (Cmax)
Pharmacokinetic parameters
Time frame: Predose and up to 24 hours postdose
Time to maximum plasma concentration of unchanged form and its metabolite (tmax)
Pharmacokinetic parameters
Time frame: Predose and up to 24 hours postdose
Area under the plasma concentration-time curve extrapolated to infinity of unchanged form and its metabolite (AUCinf)
Pharmacokinetic parameters
Time frame: Predose and up to 24 hours postdose
Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration of unchanged form and its metabolite (AUC0-last)
Pharmacokinetic parameters
Time frame: Predose and up to 24 hours postdose
Terminal elimination rate constant of unchanged form and its metabolite (λz)
Pharmacokinetic parameters
Time frame: Predose and up to 24 hours postdose
Elimination half-life of unchanged form and its metabolite (t1/2)
Pharmacokinetic parameters
Time frame: Predose and up to 24 hours postdose
Apparent volume of distribution based on the terminal phase of unchanged form (Vz/F)
Pharmacokinetic parameters
Time frame: Predose and up to 24 hours postdose
Apparent total body clearance of unchanged form (CL/F)
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.
- 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.
Taisho Director 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 TS-142 10 mg in people with Effect of Food, 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 4 inclusion and 4 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. 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?
Plasma concentration (time frame: Predose and up to 24 hours postdose). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.