Parkinson's DiseasePhase 1NCT02764892
A Study in Healthy Male Volunteers to Investigate a New Drug for the Treatment of Parkinson's Disease
A Phase 1 study testing V81444 in people with Parkinson's Disease, run by Vernalis (R&D) Ltd.
Trial summary
The main purpose of the study is to identify the best dose of V81444 to use in future trials in patients with Parkinson's disease. The study will also explore the effects of V81444 on brain activity and blood flow with tests of mental ability ("cognitive function tests"). Read more about this study
- Who is it for?
- Ages 25 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- V81444
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Mar 2013
- 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 25 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers: aged 25 to 55 years, in good general health as determined by medical history, physical examination and screening investigations, and taking no regular medication.
- Confirmation to be sought for all volunteers that their general practitioner has provided an acceptable medical history.
Who cannot join
- Any significant medical condition or a history of such a condition that the Investigator considers should exclude the subject from the study.
- Specific exclusion criteria relate to
- usual caffeine intake and willingness to abstain from caffeine
- history or evidence of clinically significant gastro-intestinal disease
- presence of structural brain abnormality
- contraindications or cautions for MRI scanning
- clotting test results
- exposure to significant levels of ionising radiation in the past
About this study
Official title: An Open Label Study of V81444 Using Positron Emission Tomography to Assess Occupancy of Brain Adenosine A2A Receptors & Functional & Perfusion MRI to Explore Effects on Regional Brain Activity & Perfusion in Healthy Male Volunteers
The main purpose of the study is to identify the best dose of V81444 to use in future trials in patients with Parkinson's disease. The study will also explore the effects of V81444 on brain activity and blood flow with tests of mental ability ("cognitive function tests"). It will also check how safe V81444 is and how well it is tolerated after dosing.
Read the detailed description
In this Phase I, single-centre, open-label, adaptive, single-dose study at multiple dose levels, the relationship between dose and plasma concentration of orally administered V81444 to brain A2A RO was investigated in 6 healthy male volunteers. In addition, the effects of V81444 on regional brain activity and perfusion during tests of cognitive function, and the safety and tolerability of V81444 were assessed. For each subject, the study consisted of a screening visit, a baseline visit, a treatment period, and a safety follow-up visit. The dose of V81444 and timing of scans performed were defined in the protocol for the first 2 subjects only. The dose, nature and timings of assessments for subsequent subjects were determined based on review of emerging receptor binding, pharmacokinetic (PK), pharmacodynamic (PD) and safety information.
In each treatment period, subjects were admitted to the unit on the day before dosing (Day -1), received a single oral dose of V81444 on Day 1 and, subject to satisfactory medical review, were discharged a minimum of 12 h after dosing. Overall, 3 doses of V81444 were assessed (250 mg, 50 mg, and 100 mg), with 2 subjects included at each dose level. PD assessments were performed at baseline and after each dose of V81444 using PET (with the A2A radioligand, to measure brain A2A RO, as well as MRI techniques to investigate the effects of V81444 on regional brain activity and perfusion during cognitive function tests. PK parameters were assessed by assay of V81444 concentration in plasma. Safety and tolerability were assessed by monitoring physical examination findings, adverse events (AEs), vital signs, 12 lead electrocardiogram (ECG) and clinical laboratory safety tests.
- Conditions
- Parkinson's Disease
- Being tested
- V81444
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V81444Drug
Single oral dose of V81444
| Study group | Role | What they receive |
|---|---|---|
| V81444 | Experimental | Single oral dose of V81444 Receives: Drug: V81444 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration V81444 corresponding with 50% brain A2A receptor occupancy.
Plasma concentrations of V81444 and binding of [11C]SCH442416 radioligand to brain A2A receptors using PET before and after V81444 dosing to determine occupancy of A2A receptors by V81444.
Measured: Up to 27 hours after a single dose
Secondary outcomes (6)
Cognitive function using functional MRI
Measured: 5 hours after dosing
Change versus placebo in proportion of subjects with adverse events
Measured: Up to 7 Days after last dose
Change versus placebo in proportion of subjects with abnormal laboratory findings
Measured: Up to 7 Days after last dose
Change versus placebo in proportion of subjects with clinically significant abnormalities on vital signs
Measured: Up to 7 Days after last dose
Change versus placebo in proportion of subjects with clinically significant abnormalities in 12-lead ECG
Measured: Up to 7 Days after last dose
Change versus placebo in proportion of subjects with clinically significant abnormalities on physical examination
Measured: Up to 7 Days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startAug 2012
- Primary completionNov 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vernalis (R&D) Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02764892
- Sponsor's protocol ID
- V81444-1PD-02
- Status last verified
- May 2016
- First submitted
- 25 Sep 2015
- Last updated
- 6 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study of V81444 Using Positron Emission Tomography to Assess Occupancy of Brain Adenosine A2A Receptors & Functional & Perfusion MRI to Explore Effects on Regional Brain Activity & Perfusion in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02764892
- Acronym / sponsor ID
- V81444-1PD-02
- Conditions
- Parkinson's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Vernalis (R&D) LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 6 May 2016 (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 main purpose of the study is to identify the best dose of V81444 to use in future trials in patients with Parkinson's disease. The study will also explore the effects of V81444 on brain activity and blood flow with tests of mental ability ("cognitive function tests"). It will also check how safe V81444 is and how well it is tolerated after dosing.
Detailed description
In this Phase I, single-centre, open-label, adaptive, single-dose study at multiple dose levels, the relationship between dose and plasma concentration of orally administered V81444 to brain A2A RO was investigated in 6 healthy male volunteers. In addition, the effects of V81444 on regional brain activity and perfusion during tests of cognitive function, and the safety and tolerability of V81444 were assessed. For each subject, the study consisted of a screening visit, a baseline visit, a treatment period, and a safety follow-up visit. The dose of V81444 and timing of scans performed were defined in the protocol for the first 2 subjects only. The dose, nature and timings of assessments for subsequent subjects were determined based on review of emerging receptor binding, pharmacokinetic (PK), pharmacodynamic (PD) and safety information.
In each treatment period, subjects were admitted to the unit on the day before dosing (Day -1), received a single oral dose of V81444 on Day 1 and, subject to satisfactory medical review, were discharged a minimum of 12 h after dosing. Overall, 3 doses of V81444 were assessed (250 mg, 50 mg, and 100 mg), with 2 subjects included at each dose level. PD assessments were performed at baseline and after each dose of V81444 using PET (with the A2A radioligand, to measure brain A2A RO, as well as MRI techniques to investigate the effects of V81444 on regional brain activity and perfusion during cognitive function tests. PK parameters were assessed by assay of V81444 concentration in plasma. Safety and tolerability were assessed by monitoring physical examination findings, adverse events (AEs), vital signs, 12 lead electrocardiogram (ECG) and clinical laboratory safety tests.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| V81444 | Experimental | Drug: V81444Single oral dose of V81444 |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male volunteers: aged 25 to 55 years, in good general health as determined by medical history, physical examination and screening investigations, and taking no regular medication.
- Confirmation to be sought for all volunteers that their general practitioner has provided an acceptable medical history.
Key exclusion criteria (8 listed)
- Any significant medical condition or a history of such a condition that the Investigator considers should exclude the subject from the study.
- Specific exclusion criteria relate to
- usual caffeine intake and willingness to abstain from caffeine
- history or evidence of clinically significant gastro-intestinal disease
- presence of structural brain abnormality
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 |
|---|---|---|
| V81444Single oral dose of V81444 | Drug | V81444 |
Primary outcome
Plasma concentration V81444 corresponding with 50% brain A2A receptor occupancy.
Time frame: Up to 27 hours after a single dose
Plasma concentrations of V81444 and binding of [11C]SCH442416 radioligand to brain A2A receptors using PET before and after V81444 dosing to determine occupancy of A2A receptors by V81444.
6 secondary outcomes
Cognitive function using functional MRI
Time frame: 5 hours after dosing
Change versus placebo in proportion of subjects with adverse events
Time frame: Up to 7 Days after last dose
Change versus placebo in proportion of subjects with abnormal laboratory findings
Time frame: Up to 7 Days after last dose
Change versus placebo in proportion of subjects with clinically significant abnormalities on vital signs
Time frame: Up to 7 Days after last dose
Change versus placebo in proportion of subjects with clinically significant abnormalities in 12-lead ECG
Time frame: Up to 7 Days after last dose
Change versus placebo in proportion of subjects with clinically significant abnormalities on physical examination
Time frame: Up to 7 Days after last dose
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 6 May 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing V81444 in people with Parkinson's Disease, run by Vernalis (R&D) Ltd.
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 2 inclusion and 8 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 6 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Plasma concentration V81444 corresponding with 50% brain A2A receptor occupancy. (time frame: Up to 27 hours after a single dose). 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 6 May 2016.