Phase 1
Completed N=100
A Study To Examine Safety, Pharmacokinetics, And Pharmacodynamic Of Pf 06412562 In Subjects With Schizophrenia
Source: ClinicalTrials.gov NCT02418819 ↗Enrolled (actual)
100
Serious AEs
1.0%
Results posted
Feb 2019
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — 10; 10; 17; 14 Participants
Summary
This study is designed to investigate the safety, tolerability pharmacokinetics and pharmacodynamic effects of PF-06412562 following multiple dose administration as MR tablets in subjects with schizophrenia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
10; 10; 17; 14; 1; 0 | — |
| PRIMARY Number of Participants With Supine and Standing Vital Signs Meeting Categorical Summarization Criteria |
1; 3; 6; 6; 1; 0 | — |
| PRIMARY Number of Participants With Electrocardiogram (ECG) (Standard 12-Lead) Data Meeting Categorical Summarization Criteria |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Blood and Urine Safety Laboratory Test Abnormalities |
9; 8; 8; 12 | — |
| PRIMARY Number of Participants With New Onset and Worsening of Post Baseline Suicidality in Columbia Suicide Severity Rating Scale (C-SSRS) on Day 1, Day 7 and Follow-up. |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Change From Baseline to Day 13 of Wechsler Memory Scale (WMS III) Spatial Span + Letter Number Span Composite Score (Working Memory Domain) |
3.95; 3.13; 1.28; 5.25 | 0.8243 |
| PRIMARY Change From Baseline in Blood Oxygen Level Dependent (BOLD) fMRI Activation Parameter Estimates (Z-scores) in Anterior Ventral Striatum Region of Interest (ROI) for the Contrast of Cue Gain > Cue No Gain in Monetary Incentive Delay (MID) Task on Day 15 |
0.045; -0.229; 0.075; -0.048 | 0.4821 |
| SECONDARY Plasma Concentrations of PF-06412562 for Each Dose. |
19.99; 61.59; 100.9; 16.14; 47.88; 79.67 | — |
| SECONDARY Plasma Concentrations of PF-06663872 at for Each Dose. |
1.707; 5.649; 8.894; 1.948; 5.355; 8.108 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects with schizophrenia both male and female
- Evidence of stable schizophrenia symptomatology for at least 3 months (no hospitalizations for schizophrenia, no increase in level of psychiatric care due to worsening of symptoms of schizophrenia, etc).
- Subjects must be in ongoing maintenance antipsychotic therapy other than clozapine (oral or depot) on a stable medication treatment regimen for for at least 2 months prior to Day 1, including concomitant psychotropic medications.
Exclusion Criteria
- History of seizure
- Pregnant or nursing females
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of screening and at the time of dosing).
Data sourced from ClinicalTrials.gov (NCT02418819). 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. Informational only — not medical advice.