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

• Status: Completed
• Trial end date: 2015-12-16
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Taisho Pharmaceutical Co., Ltd.

Criteria

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