Healthy Subjects
Conditions
Brief 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
Interventions
DRUGTS-091
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)
Sponsors
Taisho Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 39 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| H3 receptor occupancy | 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 | 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 | 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 |
Countries
Japan
Outcome results
None listed