Healthy Male SubjectsPhase 1NCT04814771
Mass Balance Study of TS-142 in Healthy Adult Subjects.
A Phase 1 study testing [14C] TS-142 in people with Healthy Male Subjects, run by Taisho Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
To assess the plasma pharmacokinetics, the routes extent of elimination, and the metabolites of TS-142 after single oral dose of [14C] TS-142 in Japanese healthy male subjects. To assess the safety of single oral dose of [14C] TS-142 in Japanese healthy male subjects. 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 Male Subjects
- What is being tested?
- [14C] TS-142
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteJapan
- Study dates
- 19 Apr 2021to 19 May 2021
- 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
- Japanese males aged >=20 and <40 years at the signing of informed consent
- Subjects whose body mass index (BMI) >=18.5 and <25.0 kg/m2 at screening
- Subjects who have no abnormal findings in the physical examination, vital signs, and standard 12-lead ECG in the screening test and the test on the day of admission and the test obtained prior to administration of the investigational drug, and whose clinical test results are within the standard values of the clinical trial site in the screening test and the test on the day of admission. However, if who showed abnormal findings but not clinically significant, they can be enrolled in clinical trials based on comprehensive consideration of medical viewpoints by the principal investigator(s) or subinvestigator(s).
- Subjects who understand, and have willingness and ability to read and sign, the informed consent form
Who cannot join
- Subjects who have received a substance labeled with a radioisotope within the last 12 months prior to dosing of the investigational drug
- Subjects who have been exposed to a large amount of radiation for therapeutic or diagnostic reasons (CT scan, stomach X-ray, PET scan etc.) within the last 12 months prior to dosing of the investigational drug
- Occupationally exposed worker in the last 12 months prior to dosing of the investigational drug
- Subjects who have had 3 days or less that one or more spontaneous defecations (defecation that occurs without laxatives, enemas, disimpaction) within 7 days before consent is obtained and during the 7 days until on the day of admission. Those who have diarrhea during the 7 days until on the day of admission
- History of any disease or surgery which have impact on investigational drug absorption such as gastrectomy, gastroenterostomy or bowel resection
- Other protocol defined exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mass Balance Recovery, Pharmacokinetics, Metabolite Identification and Profiling of 14C-labeled TS-142 in Healthy Adult Subjects.
To assess the plasma pharmacokinetics, the routes extent of elimination, and the metabolites of TS-142 after single oral dose of [14C] TS-142 in Japanese healthy male subjects.
To assess the safety of single oral dose of [14C] TS-142 in Japanese healthy male subjects.
- Conditions
- Healthy Male Subjects
- Being tested
- [14C] TS-142
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C] TS-142Drug
Subjects received single dose of 7.5 mg of TS-142 containing 20 kBq [14C]TS-142 as an oral solution
| Study group | Role | What they receive |
|---|---|---|
| [14C] TS-142 | Experimental | Participants will receive oral [14C] TS-142 under fasted conditions Receives: Drug: [14C] TS-142 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radioactivity concentration in whole blood and plasma
Measured: Up to 168 hours after dosing
Calculation of cumulative urinary and fecal recovery of total radioactivity, and calculation of mass balance as a sum of the percentages of total radioactivity recovered in urine and faeces
Measured: Up to 168 hours after dosing
Concentration of unchanged form and its major metabolites in plasma
Measured: Up to 168 hours after dosing
Percentage of TS-142 and metabolites to total radioactivity in plasma
Measured: Up to 168 hours after dosing
Percentage of TS-142 and metabolites to total radioactivity in urine and faeces
Measured: Up to 168 hours after dosing
Metabolite profiling and structural identification of metabolites in plasma, urine and faeces
Measured: Up to 168 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start19 Apr 2021
- Primary completion19 May 2021
- Study completion19 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male SubjectsStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Taisho Direcoter, Study director, Taisho Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814771
- Sponsor's protocol ID
- TS142-206
- Status last verified
- Jun 2021
- First submitted
- 22 Mar 2021
- 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
- Mass Balance Recovery, Pharmacokinetics, Metabolite Identification and Profiling of 14C-labeled TS-142 in Healthy Adult Subjects.
- ClinicalTrials.gov ID
- NCT04814771
- Acronym / sponsor ID
- TS142-206
- Conditions
- Healthy Male Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 19 May 2021 (actual)
- Study completion
- 19 May 2021 (actual)
- First posted
- 24 Mar 2021 (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.
To assess the plasma pharmacokinetics, the routes extent of elimination, and the metabolites of TS-142 after single oral dose of [14C] TS-142 in Japanese healthy male subjects.
To assess the safety of single oral dose of [14C] TS-142 in Japanese healthy male subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C] TS-142 | Experimental | Drug: [14C] TS-142Participants will receive oral [14C] TS-142 under fasted conditions |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Japanese males aged >=20 and <40 years at the signing of informed consent
- Subjects whose body mass index (BMI) >=18.5 and <25.0 kg/m2 at screening
- Subjects who have no abnormal findings in the physical examination, vital signs, and standard 12-lead ECG in the screening test and the test on the day of admission and the test obtained prior to administration of the investigational drug, and whose clinical test results are within the standard values of the clinical trial site in the screening test and the test on the day of admission. However, if who showed abnormal findings but not clinically significant, they can be enrolled in clinical trials based on comprehensive consideration of medical viewpoints by the principal investigator(s) or subinvestigator(s).
- Subjects who understand, and have willingness and ability to read and sign, the informed consent form
Key exclusion criteria (6 listed)
- Subjects who have received a substance labeled with a radioisotope within the last 12 months prior to dosing of the investigational drug
- Subjects who have been exposed to a large amount of radiation for therapeutic or diagnostic reasons (CT scan, stomach X-ray, PET scan etc.) within the last 12 months prior to dosing of the investigational drug
- Occupationally exposed worker in the last 12 months prior to dosing of the investigational drug
- Subjects who have had 3 days or less that one or more spontaneous defecations (defecation that occurs without laxatives, enemas, disimpaction) within 7 days before consent is obtained and during the 7 days until on the day of admission. Those who have diarrhea during the 7 days until on the day of admission
- History of any disease or surgery which have impact on investigational drug absorption such as gastrectomy, gastroenterostomy or bowel resection
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 |
|---|---|---|
| [14C] TS-142Subjects received single dose of 7.5 mg of TS-142 containing 20 kBq [14C]TS-142 as an oral solution | Drug | [14C] TS-142 |
Primary outcome
Radioactivity concentration in whole blood and plasma
Time frame: Up to 168 hours after dosing
Calculation of cumulative urinary and fecal recovery of total radioactivity, and calculation of mass balance as a sum of the percentages of total radioactivity recovered in urine and faeces
Time frame: Up to 168 hours after dosing
Concentration of unchanged form and its major metabolites in plasma
Time frame: Up to 168 hours after dosing
Percentage of TS-142 and metabolites to total radioactivity in plasma
Time frame: Up to 168 hours after dosing
Percentage of TS-142 and metabolites to total radioactivity in urine and faeces
Time frame: Up to 168 hours after dosing
Metabolite profiling and structural identification of metabolites in plasma, urine and faeces
Time frame: Up to 168 hours after dosing
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 Direcoter 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 [14C] TS-142 in people with Healthy Male Subjects, 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 6 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?
Radioactivity concentration in whole blood and plasma (time frame: Up to 168 hours after dosing). The study lists 6 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.