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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-11

Study Completion Date

2015-12-16

Brief Summary

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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

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Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single evaluation of H3 receptor occupancy

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

Group Type EXPERIMENTAL

TS-091

Intervention Type 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)

Multiple evaluations of H3 receptor occupancy

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

Group Type EXPERIMENTAL

TS-091

Intervention Type 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)

Interventions

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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)

Intervention Type DRUG

Eligibility Criteria

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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.

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

39 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes