CompletedPhase 1

Clinical Study on Histamine H3 Receptor Occupancy of TS-091 by PET Examination in Healthy Adult Subjects

Japan12 participantsStarted 2014-12-11

Plain-language 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

Who can participate

Age range

20 Years – 39 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 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- Exclusion Criteria: 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

H3 receptor occupancy

Timeframe: 2 hours after administration of TS-091

Changes in the H3 receptor occupancy

Timeframe: 2, 6, and 26 hours after administration of TS-091

Plasma concentration of unchanged TS-091

Timeframe: 2, 6, and 26 hours after administration of TS-091

Trial details

NCT IDNCT04631276

SponsorTaisho Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-12-16

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