Multiple Ascending Doses of PF-04958242 in Subjects With Stable Schizophrenia
| Status: | Completed |
|---|---|
| Conditions: | Schizophrenia |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/13/2015 |
| Start Date: | January 2015 |
| End Date: | April 2015 |
| Contact: | Pfizer CT.gov Call Center |
| Phone: | 1-800-718-1021 |
A Randomized, Double-blind, Placebo Controlled, Sponsor Open, Parallel Group Phase 1b Study To Examine The Safety, Tolerability And Pharmacokinetics Of Multiple Ascending Doses Of Pf-04958242 In Subjects With Stable Schizophrenia
This study aims to assess the safety, tolerability and pharmacokinetics of PF-04958242 in
multiple ascending doses in subjects with stable schizophrenia.
multiple ascending doses in subjects with stable schizophrenia.
This study aims to assess the safety, tolerability and pharmacokinetics of PF-04958242
compared to placebo over 14 days twice a day dosing in multiple ascending doses in subjects
with stable schizophrenia.
compared to placebo over 14 days twice a day dosing in multiple ascending doses in subjects
with stable schizophrenia.
Inclusion Criteria:
- Psychiatrically stable (≥3 months) male and female subjects with schizophrenia of
non-childbearing potential between the ages of 18 and 55 years, inclusive.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >55 kg (121
lbs).
- DSM-IV Diagnosis of Schizophrenia; on stable medication treatment regimen ≥2 months.
Exclusion Criteria:
- Suicide attempt within 3 months prior to screening.
- History of or risk of seizures; head injury with long term abnormal resulting
condition, abnormal EEG, clinically significant additional diseases or conditions,
current medication with a significant risk of seizures, currently receiving
antipsychotic medications.
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