SubjectPhase 1NCT02266966
Effect of F2695 on Brain Activity Measured by Functional Magnetic Resonance Imaging
A Phase 1 study testing F2695 in people with Subject, run by Pierre Fabre Medicament at 1 site in France.
Trial summary
The aim of this functional Magnetic Resonance Imaging (MRI) study is to assess the effect of single dose of F2695 at 75mg on modulation of the cerebral motor network. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Subject
- What is being tested?
- F2695
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Sep 2014
- 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 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male right-handed, healthy volunteers 18 to 40 years of age. Having signed and dated an informed consent form
Who cannot join
- Any significant disease or history of any clinically important drug allergy. Acute disease state within 7 days. History of drug abuse within 1 year. History or current excessive use of alcohol and / or positive alcohol screen. History of narrow angle glaucoma, seizures or epilepsy or brain injury. History of Gluten sensitivity, Gluten intolerance (celiac disease), Wheat allergy or Wheat intolerance.
- History of obstructive voiding symptoms, including urinary retention.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this functional Magnetic Resonance Imaging (MRI) study is to assess the effect of single dose of F2695 at 75mg on modulation of the cerebral motor network.
- Conditions
- Subject
- Being tested
- F2695, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F2695Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| F2695 | Experimental | Single dose - 2 capsules / Day on Day 1 and Day 8 Receives: Drug: F2695 |
| placebo | Placebo comparator | Single dose - 2 capsules / Day on Day 1 and Day 8 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor system cortical areas activation magnitude during a paced motor task.
- Location coordinates (x,y,z),
- Voxel cluster size expressed in terms number of voxels,
- Intensity as measured with a Z-score
Measured: 1 day (Period 1/Day +1, Period 2/Day +8)
Secondary outcomes (1)
Incidence of adverse events (AEs) as a measure of safety and tolerability
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SubjectStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Medicament
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- François Chollet, Principal investigator, Hôpital Purpan CHU TOULOUSE, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02266966
- Sponsor's protocol ID
- F02695LP105
- Status last verified
- Dec 2013
- First submitted
- 19 Sep 2014
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of F2695 on Brain Activity Measured by Functional Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT02266966
- Acronym / sponsor ID
- F02695LP105
- Conditions
- Subject
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 17 Oct 2014 (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.
The aim of this functional Magnetic Resonance Imaging (MRI) study is to assess the effect of single dose of F2695 at 75mg on modulation of the cerebral motor network.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| F2695 | Experimental | Drug: F2695Single dose - 2 capsules / Day on Day 1 and Day 8 |
| placebo | Placebo comparator | Drug: PlaceboSingle dose - 2 capsules / Day on Day 1 and Day 8 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male right-handed, healthy volunteers 18 to 40 years of age. Having signed and dated an informed consent form
Key exclusion criteria (2 listed)
- Any significant disease or history of any clinically important drug allergy. Acute disease state within 7 days. History of drug abuse within 1 year. History or current excessive use of alcohol and / or positive alcohol screen. History of narrow angle glaucoma, seizures or epilepsy or brain injury. History of Gluten sensitivity, Gluten intolerance (celiac disease), Wheat allergy or Wheat intolerance.
- History of obstructive voiding symptoms, including urinary retention.
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 |
|---|---|---|
| F2695 | Drug | F2695 |
| Placebo | Drug | placebo |
Primary outcome
Motor system cortical areas activation magnitude during a paced motor task.
Time frame: 1 day (Period 1/Day +1, Period 2/Day +8)
1. Location coordinates (x,y,z), 2. Voxel cluster size expressed in terms number of voxels, 3. Intensity as measured with a Z-score
1 secondary outcome
Incidence of adverse events (AEs) as a measure of safety and tolerability
Time frame: up to 2 weeks
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 13 Oct 2016.
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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.
François Chollet principal investigator
Hôpital Purpan CHU TOULOUSE, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing F2695 in people with Subject, run by Pierre Fabre Medicament at 1 site in France.
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 1 inclusion and 2 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 13 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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. Some participants in this study may receive a placebo. 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?
Motor system cortical areas activation magnitude during a paced motor task. (time frame: 1 day (Period 1/Day +1, Period 2/Day +8)). 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 13 Oct 2016.