Basmisanil Positron Emission Tomography Study in Japanese Volunteers

Healthy Volunteer Clinical Trial

Official title:

A Single-Centre, Non-Randomised, Open Label, Positron Emission Tomography Imaging Study to Assess Occupancy of α5-Containing GABAA Receptors by RO5186582 in Healthy Volunteers of Japanese Origin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02534207
• Other study ID #: BP29784
• Secondary ID: 2015-001621-16
• Status: Completed
• Phase: Phase 1
• First received: August 21, 2015
• Last updated: January 24, 2017
• Start date: August 2015
• Est. completion date: November 2015

Study information

• Verified date: January 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United Kingdom	Hammersmith Medicines Research; Central Middlesex Hospital	London
United Kingdom	Imanova Limited	London

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Brain a5 Subunit-Containing GABAA Receptors Occupied by Basmisanil (Receptor Occupancy) Following a Single Dose of Basmisanil in Selected Regions of Interest (ROIs) Assessed by PET Imaging		Day 1
Primary	Correlation Between Basmisanil Plasma Concentration and Occupancy of Brain a5 Subunit-Containing GABAA Receptors		Day 1
Secondary	Brain GABAA Receptor a5 Subunit Levels in Selected ROIs Assessed by PET Imaging		Day 1
Secondary	Percentage of Participants With Adverse Events		From Baseline up to 7-14 days