Phase 1 N=39 Randomized Quadruple-blind Treatment

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

Schizophrenia

Bottom Line

View on ClinicalTrials.gov: NCT02332798 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2016

Primary outcome: Primary: Maximum Observed Plasma Concentration (Cmax) (Single Dose) — 1.920; 3.830 nanograms per milliliter (ng/mL)

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: PF-04958242 (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Biogen
Primary completion: Apr 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Observed Plasma Concentration (Cmax) (Single Dose)	1.920; 3.830	—
PRIMARY Cmax (Steady State)	3.174; 7.139	—
PRIMARY Time for Cmax (Tmax) (Single Dose)	1.65; 1.33	—
PRIMARY Tmax (Steady State)	1.65; 1.33	—
PRIMARY Area Under the Concentration-Time Profile From Time 0 to Time Tau (τ), the Dosing Interval, Where τ = 12 Hours (AUCτ) (Single Dose)	9.570; 17.72	—
PRIMARY AUCτ (Steady State)	24.57; 50.09	—
PRIMARY Apparent Oral Clearance (CL/F) (Steady State)	169.5; 157.9	—
PRIMARY Apparent Volume of Distribution (Vz/F) (Steady State)	545.7; 530.2	—
PRIMARY Terminal Half-Life (t1/2) (Steady State)	39.64; 42.18	—
PRIMARY Observed Accumulation Ratio (Rac) (Steady State)	2.524; 2.815	—
PRIMARY Observed Accumulation Ratio for Cmax (Rac, Cmax) (Steady State)	1.645; 1.797	—
PRIMARY Peak-to-Trough Ratio at Steady State (PTR)	2.323; 2.531	—
PRIMARY Number of Participants With Abnormal Clinical Laboratory Measurements	4; 4; 7	—
PRIMARY Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern	0; 2; 0; 0; 1; 0	—
PRIMARY Number of Participants With Electrocardiogram Data Meeting Criteria of Potential Clinical Concern	0; 0; 0	—
PRIMARY Number of Participants With Abnormalities in Neurological Examination	0; 0; 0	—
PRIMARY Number of Participants With Abnormalities in Physical Examination	0; 0; 0	—
PRIMARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	10; 9; 4; 0; 0; 0	—
PRIMARY Number of Participants With Positive Response to Columbia-Suicide Severity Rating Scale (C-SSRS)	0; 0; 0	—

Summary

This study aims to assess the safety, tolerability and pharmacokinetics of PF-04958242 in multiple ascending doses in subjects with stable schizophrenia.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02332798). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.