Healthy VolunteerPhase 1NCT02534207
Basmisanil Positron Emission Tomography Study in Japanese Volunteers
A Phase 1 study testing Basmisanil in people with Healthy Volunteer, run by Hoffmann-La Roche at 4 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Basmisanil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Aug 2015to Nov 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Hammersmith Medicines Research; Central Middlesex Hospital
London, NW10 7EW
Study site
London, NW10 7EW
Imanova Limited
London, W12 0NN
Study site
London, W12 0NN
About this study
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
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
- Being tested
- Basmisanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BasmisanilDrug
Also called RO5186582, RG1662
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Basmisanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Correlation Between Basmisanil Plasma Concentration and Occupancy of Brain α5 Subunit-Containing GABAA Receptors
Measured: Day 1
Secondary outcomes (2)
Brain GABAA Receptor α5 Subunit Levels in Selected ROIs Assessed by PET Imaging
Measured: Day 1
Percentage of Participants With Adverse Events
Measured: From Baseline up to 7-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionOct 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02534207
- Sponsor's protocol ID
- BP29784
- Other IDs
- 2015-001621-16, 2015
- Status last verified
- Jan 2017
- First submitted
- 21 Aug 2015
- Last updated
- 26 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02534207
- Acronym / sponsor ID
- BP29784
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 27 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Basmisanil in Japanese Healthy Volunteers | Experimental | Drug: BasmisanilJapanese healthy volunteers will receive a single oral dose of RO5186582 within 15 minutes after completing a standard meal. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BasmisanilAlso: RO5186582, RG1662Single 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. | Drug | Basmisanil in Japanese Healthy Volunteers |
Primary outcome
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
Correlation Between Basmisanil Plasma Concentration and Occupancy of Brain α5 Subunit-Containing GABAA Receptors
Time frame: Day 1
2 secondary outcomes
Brain GABAA Receptor α5 Subunit Levels in Selected ROIs Assessed by PET Imaging
Time frame: Day 1
Percentage of Participants With Adverse Events
Time frame: From Baseline up to 7-14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Basmisanil in people with Healthy Volunteer, run by Hoffmann-La Roche at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2017.