Healthy SubjectsPhase 1NCT04631276
Clinical Study on Histamine H3 Receptor Occupancy of TS-091 by PET Examination in Healthy Adult Subjects
A Phase 1 study testing TS-091 in people with Healthy Subjects, run by Taisho Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
To evaluate the following items by PET examination in Japanese heathy adult male subjects who received single oral administration of TS-091 in an unblinded manner. 1. Relationship between plasma concentration and H3 receptor-occupancy of TS-091 2. Time course changes in H3 receptor-occupancy of TS-091 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-091
- 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
- 11 Dec 2014to 16 Dec 2015
- 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
- Subjects who met all of the following criteria.
- Age: between ≥20 years and <40 years at the time of providing written consent for participation in the study.
- Body mass index (BMI): ≥18.5 and <25.0 on the day of screening test.
- Subject who received a prior explanation on the study and was able to understand its content and capable of providing voluntary written consent for participation in the study.
- Other protocol defined inclusion criteria could apply-
Who cannot join
- Subjects who came under any of the following exclusion criteria.
- Subjects who were considered to have some disease and not healthy by the investigator or subinvestigator according to his medical judgment based on the results of screening test
- Subjects with a drug or food allergy or a history thereof.
- Subjects with a significant allergic disposition (e.g. asthma requiring treatment) or a history thereof.
- Subjects with a history of heparin-induced thrombocytopenia.
- Other protocol defined exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the following items by PET examination in Japanese heathy adult male subjects who received single oral administration of TS-091 in an unblinded manner.
- Relationship between plasma concentration and H3 receptor-occupancy of TS-091
- Time course changes in H3 receptor-occupancy of TS-091
- Conditions
- Healthy Subjects
- Being tested
- TS-091
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TS-091Drug
Subjects received single-dose of 0.1, 0.2, 0.4, 1, 5, 12.5 and 25 mg of TS-091 (tablets or drug substance powder)
| Study group | Role | What they receive |
|---|---|---|
| Single evaluation of H3 receptor occupancy | Experimental | Subjects received single-dose of 0.1, 0.2, 0.4, 1, 2.5, 25 mg TS-091 prior to an evaluation of H3 recepto occupancy Receives: Drug: TS-091 |
| Multiple evaluations of H3 receptor occupancy | Experimental | Subjects received single-dose of 5, 12.5, 25 mg TS-091 prior to Multiple evaluations of H3 recepto occupancy Receives: Drug: TS-091 |
What is being measured
The primary outcome is the main question the study is designed to answer.
H3 receptor occupancy
H3 receptor occupancy is calcurated at 2 hours after administration of TS-091.
Measured: 2 hours after administration of TS-091
Changes in the H3 receptor occupancy
Changes in the H3 receptor occupancy is calcurated at 2, 6, and 26 hours after administration of TS-091
Measured: 2, 6, and 26 hours after administration of TS-091
Plasma concentration of unchanged TS-091
Plasma concentration of unchanged TS-091 is calcurated at 2, 6, and 26 hours after administration of TS-091
Measured: 2, 6, and 26 hours after administration of TS-091
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start11 Dec 2014
- Primary completion16 Dec 2015
- Study completion16 Dec 2015
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 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
- Non-randomised
- Intervention model
- Single group
- 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
- NCT04631276
- Sponsor's protocol ID
- TS091-1402
- Status last verified
- Nov 2020
- First submitted
- 12 Nov 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
Publications
Kimura Y, Takahata K, Shimazaki T, Kitamura S, Seki C, Ikoma Y, Ichise M, Kawamura K, Yamada M, Zhang MR, Higuchi M, Nishino I, Suhara T. Pharmacokinetic and pharmacodynamic assessment of histamine H3 receptor occupancy by enerisant: a human PET study with a novel H3 binding ligand, [11C]TASP457. Eur J Nucl Med Mol Imaging. 2022 Mar;49(4):1127-1135. doi: 10.1007/s00259-021-05571-1. Epub 2021 Oct 15.
PubMed 34651222
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
- Clinical Study on Histamine H3 Receptor Occupancy of TS-091 by PET Examination in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04631276
- Acronym / sponsor ID
- TS091-1402
- Conditions
- Healthy Subjects
- 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
- 11 Dec 2014 (actual)
- Primary completion
- 16 Dec 2015 (actual)
- Study completion
- 16 Dec 2015 (actual)
- First posted
- 17 Nov 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.
To evaluate the following items by PET examination in Japanese heathy adult male subjects who received single oral administration of TS-091 in an unblinded manner.
- Relationship between plasma concentration and H3 receptor-occupancy of TS-091
- Time course changes in H3 receptor-occupancy of TS-091
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single evaluation of H3 receptor occupancy | Experimental | Drug: TS-091Subjects received single-dose of 0.1, 0.2, 0.4, 1, 2.5, 25 mg TS-091 prior to an evaluation of H3 recepto occupancy |
| Multiple evaluations of H3 receptor occupancy | Experimental | Drug: TS-091Subjects received single-dose of 5, 12.5, 25 mg TS-091 prior to Multiple evaluations of H3 recepto occupancy |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects who met all of the following criteria.
- Age: between ≥20 years and <40 years at the time of providing written consent for participation in the study.
- Body mass index (BMI): ≥18.5 and <25.0 on the day of screening test.
- Subject who received a prior explanation on the study and was able to understand its content and capable of providing voluntary written consent for participation in the study.
- Other protocol defined inclusion criteria could apply-
Key exclusion criteria (6 listed)
- Subjects who came under any of the following exclusion criteria.
- Subjects who were considered to have some disease and not healthy by the investigator or subinvestigator according to his medical judgment based on the results of screening test
- Subjects with a drug or food allergy or a history thereof.
- Subjects with a significant allergic disposition (e.g. asthma requiring treatment) or a history thereof.
- Subjects with a history of heparin-induced thrombocytopenia.
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-091Subjects received single-dose of 0.1, 0.2, 0.4, 1, 5, 12.5 and 25 mg of TS-091 (tablets or drug substance powder) | Drug | Multiple evaluations of H3 receptor occupancy, Single evaluation of H3 receptor occupancy |
Primary outcome
H3 receptor occupancy
Time frame: 2 hours after administration of TS-091
H3 receptor occupancy is calcurated at 2 hours after administration of TS-091.
Changes in the H3 receptor occupancy
Time frame: 2, 6, and 26 hours after administration of TS-091
Changes in the H3 receptor occupancy is calcurated at 2, 6, and 26 hours after administration of TS-091
Plasma concentration of unchanged TS-091
Time frame: 2, 6, and 26 hours after administration of TS-091
Plasma concentration of unchanged TS-091 is calcurated at 2, 6, and 26 hours after administration of TS-091
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.
- Derived from this study: PubMed 34651222Kimura Y, Takahata K, Shimazaki T, Kitamura S, Seki C, Ikoma Y, Ichise M, Kawamura K, Yamada M, Zhang MR, Higuchi M, Nishino I, Suhara T. Pharmacokinetic and pharmacodynamic assessment of histamine H3 receptor occupancy by enerisant: a human PET study with a novel H3 binding ligand, [11C]TASP457. Eur J Nucl Med Mol Imaging. 2022 Mar;49(4):1127-1135. doi: 10.1007/s00259-021-05571-1. Epub 2021 Oct 15.
- 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-091 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 5 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?
H3 receptor occupancy (time frame: 2 hours after administration of TS-091). The study lists 3 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 NCT04631276, 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.