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

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: TS-091

• Registration Number: NCT04631276
• Lead Sponsor: Taisho Pharmaceutical Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-11
• Primary Completion: 2015-12-16
• Study Completion: 2015-12-16
• Status Verified: 2020-11
• Study First Submitted: 2020-11-12
• Study First Submitted QC: 2020-11-12
• Study First Posted: 2020-11-17
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single evaluation of H3 receptor occupancy	TS-091	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
Multiple evaluations of H3 receptor occupancy	TS-091	Subjects received single-dose of 5, 12.5, 25 mg TS-091 prior to Multiple evaluations of H3 recepto occupancy

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Taisho Pharmaceutical Co., Ltd selected site; 🇯🇵 Tokyo, Japan