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This study will assess the relative bioavailability of a capsule formulation of PF-04958242, relative to a oral solution formulation of PF-04958242 in healthy adult subjects.
This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-04958242 capsule | Experimental |
| |
| PF-04958242 oral solution | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04958242 capsule | Drug | Single dose of PF-04958242 0.35 mg oral capsule |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose | |
| Maximum Observed Plasma Concentration (Cmax) | 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04958242 | 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose | |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] | 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose | |
| Plasma Decay Half-Life (t1/2) | 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose | |
| Apparent Oral Clearance (CL/F) | 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose | |
| Apparent Volume of Distribution (Vz/F) | 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose | |
| Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | 4 and 192 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| no secondary endpoints | no secondary endpoints |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | New Haven | Connecticut | 06511 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000600968 | PF-04958242 |
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| PF-04958242 oral solution |
| Drug |
Single dose of PF-04958242 0.35 mg oral solution |
|