Basmisanil Positron Emission Tomography Study in Japanese Volunteers

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2015-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will evaluate the relationship between basmisanil plasma concentrations and the occupancy of Gamma-Amino Butyric Acid A (GABAA) receptor subtypes containing an alpha5 (α5) subunit in healthy Japanese volunteers. Each participant will have two post-screening imaging sessions. In the first imaging session, participants will have a baseline Positron Emission Tomography (PET) scan. In the second imaging session, participants will receive a single oral dose of basmisanil, followed by two on-treatment PET scans at about 4 and 10 hours post-dose.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

PET Study of Repeated ASN51 in Healthy Volunteers

NCT05725005

Healthy

COMPLETED PHASE1

Study of Melanoma-Resistant PET Monitoring Based on Key Rate-limiting Enzymes for Fatty Acid Metabolism in Healthy Volunteers

NCT07114172

Melanoma (Skin Cancer) Health Volunteers PET / CT

NOT_YET_RECRUITING NA

Radiation Dosimetry, Metabolism, Safety, Tolerability and Positron Emission Tomography/Computed Tomography (PET/CT) Imaging With BAY 85-8050 in Healthy Volunteers and Patients

NCT00961831

Neoplasm

COMPLETED PHASE1

PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Safety and Tolerability in Healthy Volunteers and Safety, Tolerability and Diagnostic Performance of BAY86-9596 in Patients With Non-small Cell Lung Cancer, Breast Cancer, Head and Neck Cancer and Patients With Inflammations

NCT01089998

Diagnostic Imaging

COMPLETED PHASE1

A PET Study to Determine Biodistribution and Binding Characteristics of [11C]AZ14132516 in Healthy Participants

NCT05818514

Healthy Volunteers

COMPLETED EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Basmisanil in Japanese Healthy Volunteers

Japanese healthy volunteers will receive a single oral dose of RO5186582 within 15 minutes after completing a standard meal.

Group Type EXPERIMENTAL

Basmisanil

Intervention Type DRUG

Single oral dose: Basmisanil doses between 20 milligrams (mg) and 960 mg may be used in this study. The planned doses for the first two participants are 160 mg and 480 mg, respectively. Basmisanil dose for subsequent participants will be decided by the investigator and sponsor during the study, based on on-going review of emerging data.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Basmisanil

Single oral dose: Basmisanil doses between 20 milligrams (mg) and 960 mg may be used in this study. The planned doses for the first two participants are 160 mg and 480 mg, respectively. Basmisanil dose for subsequent participants will be decided by the investigator and sponsor during the study, based on on-going review of emerging data.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

RO5186582, RG1662

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male or female Japanese healthy volunteer, who was born in Japan, has 4 ethnically Japanese grandparents and has lived outside Japan for no longer than 5 years
* A body mass index (BMI, Quetelet index) in the range 18.0 to 32.0 kilograms per square meter (kg/m\^2)
* Willingness and ability to comply with study restrictions

Exclusion Criteria

* A history of epilepsy, convulsions or significant head injury, or other structural brain abnormality
* Pregnant or lactating or not using acceptable contraception
* Presence or history of severe adverse reaction to any drug or a history of sensitivity to basmisanil or the PET radioligand (RO15-4513)
* Significant exposure to radiation within the previous 12 months
* Any other clinically relevant abnormalities, concomitant diseases or ongoing medical conditions

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes