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

Taisho Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: TS-091

Study type: Interventional

Funder types: Industry

Identifiers

NCT04631276

TS091-1402

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: Male

Ages: 20 to 39 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 2 patient groups

Single evaluation of H3 receptor occupancy

Experimental group

Description:

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

Treatment:

Drug: TS-091

Multiple evaluations of H3 receptor occupancy

Experimental group

Description:

Subjects received single-dose of 5, 12.5, 25 mg TS-091 prior to Multiple evaluations of H3 recepto occupancy

Treatment:

Drug: TS-091