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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002733-38 | EudraCT Number |
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This Phase 1 study will evaluate PDE10 enzyme occupancy using Positron Emission Tomography after a single dose of PF-02545920 in Healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 - 20 mg | Experimental | Cohort will include 4 HVs/completers who will receive a single 20 mg dose of PF-02545920. |
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| 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. |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 20 mg PF-02545920 | Drug | Subject will receive a single dose of 20 mg PF-02545920. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Trial Alliance (KTA) M62 | Huddinge | Stockholm County | SE- 141 86 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28122201 | Derived | 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. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| C545121 | 2-((4-(1-methyl-4-pyridin-4-yl-1H-pyrazol-3-yl)phenoxy)methyl)quinoline |
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| PF-02545920 |
| Drug |
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. |
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| PF-02545920 | Drug | The dose will be selected based on the results obtained for Cohort 1 and cohort 2. |
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| Maximum Observed Plasma Concentration (Cmax) | Cmax for serum PF-02545920 during the post-dose positron emission tomography (PET) scan. | Day 10 |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | Tmax for serum PF-02545920 during the post-dose positron emission tomography (PET) scan. | Day 10 |
| Average serum concentration | Average serum 02545920 during the post-dose positron emission tomography (PET) scan. | Day 10 |