Phase 1
Completed N=37
A Study To Examine The Safety, Tolerability And Pharmacokinetics Of PF-02545920 In Psychiatrically Stable Subjects With Schizophrenia
Source: ClinicalTrials.gov NCT01829048 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcomePrimary: Change From Baseline in Abbreviated Extrapyramidal Symptom Rating Scale (ESRS-A) Scores (Cohorts 1 and 2) at Day 10 — -0.2; -0.3; 0.1; 0.0 Units on a scale
Summary
To evaluate the safety and tolerability of multiple doses of PF 02545920 administered orally to psychiatrically stable subjects with schizophrenia receiving background antipsychotic +/- other adjunctive medication.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Abbreviated Extrapyramidal Symptom Rating Scale (ESRS-A) Scores (Cohorts 1 and 2) at Day 10 |
-0.2; -0.3; 0.1; 0.0; 0.0; -0.1 | — |
| PRIMARY Change From Baseline in ESRS-A Scores (Cohort 3) at Day 18 |
0.3; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) (Cohorts 1 and 2) at Baseline (Day 0) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Response to C-SSRS (Cohorts 1 and 2) at Day 11 |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Response to C-SSRS (Cohorts 1 and 2) at Follow-up (Any Day Between Day 17 and 20) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Response to C-SSRS (Cohort 3) at Baseline (Day 0) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Response to C-SSRS (Cohort 3) at Day 19 |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Response to C-SSRS (Cohort 3) at Follow-up (Any Day Between Day 26 and 29) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Changes Since Screening in Physical Examination (Cohorts 1 and 2) |
0; 0; 0 | — |
| PRIMARY Number of Participants With Changes Since Screening in Physical Examination (Cohort 3) |
1; 0 | — |
| PRIMARY Number of Participants With Abnormal Neurological Examination Findings (Cohorts 1 and 2) |
2; 0; 1 | — |
| PRIMARY Number of Participants With Abnormal Neurological Examination Findings (Cohort 3) |
0; 0 | — |
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Cohorts 1 and 2) |
5; 5; 3 | — |
| PRIMARY Number of Participants With TEAEs (Cohort 3) |
9; 1 | — |
| PRIMARY Number of Participants With Abnormal Clinical Laboratory Measurements (Cohorts 1 and 2) |
4; 4; 5 | — |
| PRIMARY Number of Participants With Abnormal Clinical Laboratory Measurements (Cohort 3) |
11; 0 | — |
| PRIMARY Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern (Cohorts 1 and 2) |
1; 1; 0; 0; 1; 0 | — |
| PRIMARY Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern (Cohort 3) |
2; 0; 1; 1; 1; 0 | — |
| PRIMARY Number of Participants With Electrocardiogram (ECG) Data Meeting Criteria of Potential Clinical Concern (Cohorts 1 and 2) |
0; 0; 0 | — |
| PRIMARY Number of Participants With ECG Data Meeting Criteria of Potential Clinical Concern (Cohort 3) |
0; 0 | — |
| PRIMARY Sparse Pharmacokinetic (PK) Sampling for Population PK Analysis: PF-02545920 Concentration at 0 Hour (Predose) on Day 10 (Cohorts 1 and 2) |
45.07; 40.25 | — |
| PRIMARY Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 25 Minutes (Post Dose) on Day 10 (Cohorts 1 and 2) |
116.8; 138.3 | — |
| PRIMARY Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 1 Hour 30 Minutes (Post Dose) on Day 10 (Cohorts 1 and 2) |
154.0; 151.1 | — |
| PRIMARY Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 5 Hours (Post Dose) on Day 10 (Cohorts 1 and 2) |
62.38; 59.15 | — |
| PRIMARY Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 24 Hours (Post Dose) on Day 10 (Cohorts 1 and 2) |
24.16; 21.11 | — |
| PRIMARY Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 0 Hour (Predose) on Day 18 (Cohort 3) |
42.71 | — |
| PRIMARY Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 25 Minutes (Post Dose) on Day 18 (Cohort 3) |
156.1 | — |
| PRIMARY Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 1 Hour 30 Minutes (Post Dose) on Day 18 (Cohort 3) |
156.4 | — |
| PRIMARY Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 5 Hours (Post Dose) on Day 18 (Cohort 3) |
61.30 | — |
| PRIMARY Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 24 Hours (Post Dose) on Day 18 (Cohort 3) |
20.85 | — |
Eligibility Criteria
Inclusion Criteria
- Psychiatrically stable subjects with schizophrenia.
- Evidence of stable schizophrenia symptomatology greater than or equal to 3 months.
- Subjects must be on a stable medication treatment regimen greater than or equal to 2 months, including concomitant psychotropic medications.
Exclusion Criteria
- History of seizures or of a condition with risk of seizures.
- Subjects who have had electroconvulsive therapy within the 6 months prior to randomization.
- Pregnant or nursing females, and females of child bearing potential.
Data sourced from ClinicalTrials.gov (NCT01829048). 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.