Basmisanil Positron Emission Tomography Study in Japanese Volunteers

NCT02534207 | Completed Phase 1

• 2 other identifiers: BP297842015-001621-16
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• Percentage of Brain α5 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

• Correlation Between Basmisanil Plasma Concentration and Occupancy of Brain α5 Subunit-Containing GABAA Receptors

  Day 1

Secondary Outcomes (2)

• Brain GABAA Receptor α5 Subunit Levels in Selected ROIs Assessed by PET Imaging

  Day 1

• Percentage of Participants With Adverse Events

  From Baseline up to 7-14 days

Study Arms (1)

Basmisanil in Japanese Healthy Volunteers

EXPERIMENTAL

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

Drug: Basmisanil

Interventions

Basmisanil 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.

Also known as: RO5186582, RG1662

Basmisanil in Japanese Healthy Volunteers

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (4)

Hammersmith Medicines Research; Central Middlesex Hospital

London, NW10 7EW, United Kingdom

Location

Unknown Facility

London, NW10 7EW, United Kingdom

Location

Imanova Limited

London, W12 0NN, United Kingdom

Location

Unknown Facility

London, W12 0NN, United Kingdom

Location

MeSH Terms

Interventions

basmisanil

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2015
• First Posted: August 27, 2015
• Study Start: August 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 26, 2017

Record last verified: 2017-01

Locations

GB (4)