Healthy SubjectsPhase 1NCT04557163
Drug-drug Interaction Study with TS-142 in Healthy Adult Subjects (concomitant Administration of Itraconazole)
A Phase 1 study testing TS-142 and Itraconazole in people with Healthy Subjects, run by Taisho Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
This is an open-label, single-center, single-sequence study to evaluate the concomitant effects of the potent CYP3A inhibitor itraconazole on the single-dose pharmakokinetics, safety and tolerability of oral TS-142 in healthy 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 Subjects
- What is being tested?
- TS-142 and Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteJapan
- Study dates
- 13 Oct 2020to 14 Nov 2020
- 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 male age 20 to 39 years at the signing of informed consent
- Subjects whose body mass index (BMI) within the range 18.5 - 25.0 kg/m2, exclusive of 25.0
- Subjects who judged by the principal investigator(s) or subinvestigator(s) to be appropriate as a subjects of this study based on the results of screening tests and the tests obtained prior to the administration of the investigational drug. (Those who have no abnormal findings in the physical examination, vital signs, and standard 12-lead ECG in the screening test 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. 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 any disease and are judged not to be healthy based on the medical viewpoints by the principal investigator(s) or subinvestigator(s)
- Subjects who have an inappropriate history for participation in this study, including hepatic, renal, cardiovascular, hematological, endocrinological, metabolic, respiratory, gastrointestinal, dermatological, neurological, urological, immunological, psychiatric abnormalities or diseases
- Subjects who have any history of drug or food allergies
- Other protocol defined exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
This is an open-label, single-center, single-sequence study to evaluate the concomitant effects of the potent CYP3A inhibitor itraconazole on the single-dose pharmakokinetics, safety and tolerability of oral TS-142 in healthy subjects.
- Conditions
- Healthy Subjects
- Being tested
- TS-142, Itraconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TS-142Drug
TS-142 will be given as 1 mg per capsule administered orally with water.
ItraconazoleDrug
Itraconazole will given as 50 mg per capsule administered orally with water.
| Study group | Role | What they receive |
|---|---|---|
| Subjects receiving TS-142 and itraconazole | Experimental | Eligible subjects will receive a single dose of 5 mg TS-142 on Day 1. Subjects will also receive twice-a-day of 200 mg itraconazole on Day 3 and an once-daily single dose of 200 mg itraconazole from Day 4 to Day 7 and single dose of 1 mg TS-142 on Day 6. Receives: Drug: TS-142; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum observed concentration of unchanged form of TS-142 and its metabolite in plasma.
Measured: Sampling at pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 48 hours post-dose of TS-142 on Day 1 or Day 6, in addition, at 96, 144, 192, 240 hours post-dose of TS-142 on Day 6.
Secondary outcomes (1)
AUC(0-last)
Area under the concentration-time curve from time zero to time of the last quantifiable concentration of TS-142 and its metabolite in plasma.
Measured: Sampling at pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 48 hours post-dose of TS-142 on Day 1 or Day 6, in addition, at 96, 144, 192, 240 hours post-dose of TS-142 on Day 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start13 Oct 2020
- Primary completion14 Nov 2020
- Study completion14 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT04557163
- Sponsor's protocol ID
- TS-142-205-01
- Status last verified
- Nov 2020
- First submitted
- 18 Sep 2020
- 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
- Drug-drug Interaction Study with TS-142 in Healthy Adult Subjects (concomitant Administration of Itraconazole)
- ClinicalTrials.gov ID
- NCT04557163
- Acronym / sponsor ID
- TS-142-205-01
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 14 Nov 2020 (actual)
- Study completion
- 14 Nov 2020 (actual)
- First posted
- 21 Sep 2020 (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 an open-label, single-center, single-sequence study to evaluate the concomitant effects of the potent CYP3A inhibitor itraconazole on the single-dose pharmakokinetics, safety and tolerability of oral TS-142 in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects receiving TS-142 and itraconazole | Experimental | Drug: TS-142, Drug: ItraconazoleEligible subjects will receive a single dose of 5 mg TS-142 on Day 1. Subjects will also receive twice-a-day of 200 mg itraconazole on Day 3 and an once-daily single dose of 200 mg itraconazole from Day 4 to Day 7 and single dose of 1 mg TS-142 on Day 6. |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Japanese male age 20 to 39 years at the signing of informed consent
- Subjects whose body mass index (BMI) within the range 18.5 - 25.0 kg/m2, exclusive of 25.0
- Subjects who judged by the principal investigator(s) or subinvestigator(s) to be appropriate as a subjects of this study based on the results of screening tests and the tests obtained prior to the administration of the investigational drug. (Those who have no abnormal findings in the physical examination, vital signs, and standard 12-lead ECG in the screening test 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. 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 (4 listed)
- Subjects who have any disease and are judged not to be healthy based on the medical viewpoints by the principal investigator(s) or subinvestigator(s)
- Subjects who have an inappropriate history for participation in this study, including hepatic, renal, cardiovascular, hematological, endocrinological, metabolic, respiratory, gastrointestinal, dermatological, neurological, urological, immunological, psychiatric abnormalities or diseases
- Subjects who have any history of drug or food allergies
- 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-142TS-142 will be given as 1 mg per capsule administered orally with water. | Drug | Subjects receiving TS-142 and itraconazole |
| ItraconazoleItraconazole will given as 50 mg per capsule administered orally with water. | Drug | Subjects receiving TS-142 and itraconazole |
Primary outcome
Cmax
Time frame: Sampling at pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 48 hours post-dose of TS-142 on Day 1 or Day 6, in addition, at 96, 144, 192, 240 hours post-dose of TS-142 on Day 6.
Maximum observed concentration of unchanged form of TS-142 and its metabolite in plasma.
1 secondary outcome
AUC(0-last)
Time frame: Sampling at pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 48 hours post-dose of TS-142 on Day 1 or Day 6, in addition, at 96, 144, 192, 240 hours post-dose of TS-142 on Day 6.
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 and Itraconazole in people with Healthy 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 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?
Cmax (time frame: Sampling at pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 48 hours post-dose of TS-142 on Day 1 or Day 6, in addition, at 96, 144, 192, 240 hours post-dose of TS-142 on Day 6.). 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.