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

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

Completed

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Key information

Conditions

Healthy Subjects

Age range

20 year–39 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TS-091

Drug

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)

Primary outcomes

H3 receptor occupancy

Time frame: 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

Time frame: 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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Taisho Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Nov 17, 2020
Registry last updated: Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed