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Basmisanil Positron Emission Tomography Study in Japanese Volunteers

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ClinicalTrials.gov Identifier: NCT02534207
Recruitment Status : Completed
First Posted : August 27, 2015
Last Update Posted : January 26, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: Basmisanil Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Study Start Date : August 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : November 2015

Arm Intervention/treatment
Experimental: Basmisanil in Japanese Healthy Volunteers
Japanese healthy volunteers will receive a single oral dose of RO5186582 within 15 minutes after completing a standard meal.
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.
Other Name: RO5186582, RG1662




Primary Outcome Measures :
  1. 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 [ Time Frame: Day 1 ]
  2. Correlation Between Basmisanil Plasma Concentration and Occupancy of Brain α5 Subunit-Containing GABAA Receptors [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. Brain GABAA Receptor α5 Subunit Levels in Selected ROIs Assessed by PET Imaging [ Time Frame: Day 1 ]
  2. Percentage of Participants With Adverse Events [ Time Frame: From Baseline up to 7-14 days ]


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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02534207


Locations
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United Kingdom
Hammersmith Medicines Research; Central Middlesex Hospital
London, United Kingdom, NW10 7EW
London, United Kingdom, NW10 7EW
Imanova Limited
London, United Kingdom, W12 0NN
London, United Kingdom, W12 0NN
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02534207     History of Changes
Other Study ID Numbers: BP29784
2015-001621-16 ( EudraCT Number )
First Posted: August 27, 2015    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017