HealthyPhase 1PETNCT01918202
A Study To Evaluate The PDE10 Enzyme Occupancy Following A Single Dose Of PF-02545920 In Healthy Male Volunteers
A Phase 1 study testing 20 mg PF-02545920 and PF-02545920 in people with Healthy, run by Pfizer at 1 site in Sweden.
Trial summary
This Phase 1 study will evaluate PDE10 enzyme occupancy using Positron Emission Tomography after a single dose of PF-02545920 in Healthy male volunteers. Read more about this study
- Who is it for?
- Ages 21 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 20 mg PF-02545920 and PF-02545920
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSweden
- Study dates
- Mar 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 21 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy male volunteers
Who cannot join
- History of orthostatic hypotension
- History of prior radiation exposure for research purposes, or radiation therapy
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Trial Alliance (KTA) M62
Huddinge, Stockholm County, SE- 141 86
About this study
Official title: A Phase 1, Open-label Adaptive Design Study To Evaluate Pde10 Enzyme Occupancy As Measured By Positron Emission Tomography (Pet) Following Single Oral Dose Administration Of Pf-02545920 In Healthy Male Subjects
This Phase 1 study will evaluate PDE10 enzyme occupancy using Positron Emission Tomography after a single dose of PF-02545920 in Healthy male volunteers.
- Conditions
- Healthy
- Being tested
- 20 mg PF-02545920, PF-02545920
- Keywords
- Enzyme occupancy, PET, Phosphodiesterase 10 inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20 mg PF-02545920Drug
Subject will receive a single dose of 20 mg PF-02545920.
PF-02545920Drug
The dose will be selected based on the results obtained for Cohort 1. Dose options range from 30 mg to 10 mg, 5 mg, 2mg, 1 mg.
This cohort is optional.
PF-02545920Drug
The dose will be selected based on the results obtained for Cohort 1 and cohort 2.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - 20 mg | Experimental | Cohort will include 4 HVs/completers who will receive a single 20 mg dose of PF-02545920. Receives: Drug: 20 mg PF-02545920 |
| Cohort 2 ( adaptive dose, optional) | Experimental | Cohort 2 will include 4 HVs/completers who will receive a single dose of PF-02545920. The dose will be selected based on the results obtained for Cohort 1. Receives: Drug: PF-02545920 |
| Cohort 3 ( adaptive dose, optional) | Experimental | Cohort 3 will include 4 HVs/completers who will receive a single dose of PF-02545920. The dose will be selected based on the results obtained for Cohort 1.
Dose options range from 30 mg to 10 mg, 5 mg, 2mg, 1 mg. This cohort is optional Receives: Drug: PF-02545920 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central PDE10A enzyme occupancy values in the striatum.
Using Positron Emission Tomography and a radiotracer (MNI-659) for PF-02545920, the central PDE10A enzyme occupancy values will be measured in the striatum at different single oral doses of PF-02545920.
Measured: Day 10
Secondary outcomes (4)
Central PDE10A enzyme occupancy values in the globus pallidus, in the caudate and in the putamen (separately).
Using Positron Emission Tomography and a radiotracer (MNI-659) for PF-02545920, central PDE10A enzyme occupancy values in the globus pallidus, in the caudate and in the putamen be measured (separately) at different single oral doses of PF-02545920.
Measured: Day 10
Maximum Observed Plasma Concentration (Cmax)
Cmax for serum PF-02545920 during the post-dose positron emission tomography (PET) scan.
Measured: Day 10
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Tmax for serum PF-02545920 during the post-dose positron emission tomography (PET) scan.
Measured: Day 10
Average serum concentration
Average serum 02545920 during the post-dose positron emission tomography (PET) scan.
Measured: Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
- Study startMar 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918202
- Sponsor's protocol ID
- A8241017
- Other IDs
- 2013-002733-38
- Acronym
- PET
- Status last verified
- Nov 2014
- First submitted
- 5 Aug 2013
- Last updated
- 10 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Delnomdedieu M, Forsberg A, Ogden A, Fazio P, Yu CR, Stenkrona P, Duvvuri S, David W, Al-Tawil N, Vitolo OV, Amini N, Nag S, Halldin C, Varrone A. In vivo measurement of PDE10A enzyme occupancy by positron emission tomography (PET) following single oral dose administration of PF-02545920 in healthy male subjects. Neuropharmacology. 2017 May 1;117:171-181. doi: 10.1016/j.neuropharm.2017.01.016. Epub 2017 Jan 22.
PubMed 28122201
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Adaptive Design Study To Evaluate Pde10 Enzyme Occupancy As Measured By Positron Emission Tomography (Pet) Following Single Oral Dose Administration Of Pf-02545920 In Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01918202
- Acronym / sponsor ID
- PET / A8241017
- Conditions
- Healthy
- Keywords
- Enzyme occupancy, PET, Phosphodiesterase 10 inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 7 Aug 2013 (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 Phase 1 study will evaluate PDE10 enzyme occupancy using Positron Emission Tomography after a single dose of PF-02545920 in Healthy male volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - 20 mg | Experimental | Drug: 20 mg PF-02545920Cohort will include 4 HVs/completers who will receive a single 20 mg dose of PF-02545920. |
| Cohort 2 ( adaptive dose, optional) | Experimental | Drug: PF-02545920Cohort 2 will include 4 HVs/completers who will receive a single dose of PF-02545920. The dose will be selected based on the results obtained for Cohort 1. |
| Cohort 3 ( adaptive dose, optional) | Experimental | Drug: PF-02545920Cohort 3 will include 4 HVs/completers who will receive a single dose of PF-02545920. The dose will be selected based on the results obtained for Cohort 1. Dose options range from 30 mg to 10 mg, 5 mg, 2mg, 1 mg. This cohort is optional |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy male volunteers
Key exclusion criteria (2 listed)
- History of orthostatic hypotension
- History of prior radiation exposure for research purposes, or radiation therapy
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 |
|---|---|---|
| 20 mg PF-02545920Subject will receive a single dose of 20 mg PF-02545920. | Drug | Cohort 1 - 20 mg |
| PF-02545920The dose will be selected based on the results obtained for Cohort 1. Dose options range from 30 mg to 10 mg, 5 mg, 2mg, 1 mg. This cohort is optional. | Drug | Cohort 2 ( adaptive dose, optional) |
| PF-02545920The dose will be selected based on the results obtained for Cohort 1 and cohort 2. | Drug | Cohort 3 ( adaptive dose, optional) |
Primary outcome
Central PDE10A enzyme occupancy values in the striatum.
Time frame: Day 10
Using Positron Emission Tomography and a radiotracer (MNI-659) for PF-02545920, the central PDE10A enzyme occupancy values will be measured in the striatum at different single oral doses of PF-02545920.
4 secondary outcomes
Central PDE10A enzyme occupancy values in the globus pallidus, in the caudate and in the putamen (separately).
Time frame: Day 10
Maximum Observed Plasma Concentration (Cmax)
Time frame: Day 10
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Day 10
Average serum concentration
Time frame: Day 10
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 10 Nov 2014.
- Derived from this study: PubMed 28122201Delnomdedieu M, Forsberg A, Ogden A, Fazio P, Yu CR, Stenkrona P, Duvvuri S, David W, Al-Tawil N, Vitolo OV, Amini N, Nag S, Halldin C, Varrone A. In vivo measurement of PDE10A enzyme occupancy by positron emission tomography (PET) following single oral dose administration of PF-02545920 in healthy male subjects. Neuropharmacology. 2017 May 1;117:171-181. doi: 10.1016/j.neuropharm.2017.01.016. Epub 2017 Jan 22.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
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 20 mg PF-02545920 and PF-02545920 in people with Healthy, run by Pfizer at 1 site in Sweden.
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 10 Nov 2014. 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 Sweden. 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?
Central PDE10A enzyme occupancy values in the striatum. (time frame: Day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01918202, which also lists 1 linked publication.
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 10 Nov 2014; AzTrials last refreshed its copy on 4 Nov 2026.