Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the safety and tolerability of multiple, ascending doses of PF-04958242 administered orally to psychiatrically stable subjects with schizophrenia receiving antipsychotic and adjunctive medication.
This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-04958242 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04958242 | Drug | PF-04958242 0.10 mg oral solution Q24 hours for 14 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of Pharmacokinetics measured at 0.25, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24 hours after dosing on Day 1 | Day 1 - Day 2 | |
| Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 4 | Day 4 | |
| Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 7 | Day 7 | |
| Composite of Pharmacokinetics measured at 0.25, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24, 48, 72, 120 hours after dosing on Day 14 | Day 14 - Day 17 | |
| Composite of urine Pharmacokinetics measured for 24 hours post-dose on Day 14 | Day 14 - Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Cogntion - CogState | Day 0, 1, 6, 13 | |
| Cognition - Matrics Consensus Cognition Battery | Day 0, 1, 6, 13 | |
| Drug Effect Questionnaire liking scale |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Long Beach | California | 90806 | United States |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000600968 | PF-04958242 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| PF-04958242 |
| Drug |
PF-04958242 0.20 mg oral solution Q24 hours for 14 days |
|
| PF-04958242 | Drug | PF-04958242 oral solution Q24 hours for 14 days (dose to be determined) |
|
| Placebo | Drug | Placebo oral solution Q24 hours for 14 days |
|
| Day, 1, 14 |
| Cognitive training | Days 0 - 13 |
| Columbia Suicide Severity Rating Scale | Day 0, 1, 7, 14, 17, 23 |