Overview

Multiple Ascending Doses of PF-04958242 in Subjects With Stable Schizophrenia

Status:
Completed
Trial end date:
2015-04-15
Target enrollment:
0
Participant gender:
All
Summary
This study aims to assess the safety, tolerability and pharmacokinetics of PF-04958242 in multiple ascending doses in subjects with stable schizophrenia.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Biogen
Pfizer
Criteria
Key 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.

Key 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.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply