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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04631276
• Other study ID #: TS091-1402
• Status: Completed
• Phase: Phase 1
• Start date: December 11, 2014
• Est. completion date: December 16, 2015

Study information

• Verified date: November 2020
• Source: Taisho Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 16, 2015
• Est. primary completion date: December 16, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• TS-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)

Locations

Country	Name	City	State
Japan	Taisho Pharmaceutical Co., Ltd selected site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Taisho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	H3 receptor occupancy	H3 receptor occupancy is calcurated at 2 hours after administration of TS-091.	2 hours after administration of TS-091
Primary	Changes in the H3 receptor occupancy	Changes in the H3 receptor occupancy is calcurated at 2, 6, and 26 hours after administration of TS-091	2, 6, and 26 hours after administration of TS-091
Primary	Plasma concentration of unchanged TS-091	Plasma concentration of unchanged TS-091 is calcurated at 2, 6, and 26 hours after administration of TS-091	2, 6, and 26 hours after administration of TS-091