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

Study Overview
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Brief Summary
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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

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

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: TS-091


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single evaluation of H3 receptor occupancy<br>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 | Drug: TS-091<br>* 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)<br>|
| Experimental: Multiple evaluations of H3 receptor occupancy<br>Subjects received single-dose of 5, 12.5, 25 mg TS-091 prior to Multiple evaluations of H3 recepto occupancy | Drug: TS-091<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| H3 receptor occupancy | H3 receptor occupancy is calcurated at 2 hours after administration of TS-091. | 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 | 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 | 2, 6, and 26 hours after administration of TS-091 |