A Study To Examine Safety, Pharmacokinetics, And Pharmacodynamic Of Pf 06412562 In Subjects With Schizophrenia

Phase 1 Completed 103 enrolled Pfizer

RandomizedParallel-groupDouble-blindBasic science

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.

Timeline

Start: 2015-04
Primary completion: 2016-10
Completion: 2016-10

Outcome

Missed primary endpoint

registry analysis (superiority or other test); PF-06412562 3 mg BID vs Placebo; p = 0.8243; LSMean difference from placebo -1.90; ANCOVA NCT02418819 ↗

registry analysis (superiority or other test); PF-06412562 3 mg BID vs Placebo; p = 0.4821; LSMean difference from placebo 0.0129; ANCOVA NCT02418819 ↗

Publications

Arce E, Balice-Gordon R, Duvvuri S, Naylor M, Xie Z, Harel B, Kozak R, Gray DL, DeMartinis N. A novel approach to evaluate the pharmacodynamics of a selective dopamine D1/D5 receptor partial agonist (PF-06412562) in patients with stable schizophrenia. J Psychopharmacol. 2019 Oct;33(10):1237-1247. doi: 10.1177/0269881119855302. Epub 2019 Jul 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PF-06412562	Unknown	3 mg	Oral
Subject	PF-06412562	Unknown	9 mg	Oral
Subject	PF-06412562	Unknown	45 mg	Oral