PF-06669571 In Subjects With Idiopathic Parkinson's Disease

Phase 1 Completed 20 enrolled Pfizer

RandomizedParallel-groupDouble-blindBasic science

Summary

This study is designed to assess safety, tolerability and pharmacokinetic data for multiple doses of PF-06669571 in subjects with idiopathic Parkinson's disease. In addition, this study will assess whether PF-06669571 is able to demonstrate superior efficacy compared with placebo in the treatment of the motor symptoms of idiopathic Parkinson's disease.

Timeline

Start: 2015-11-16
Primary completion: 2016-05-13
Completion: 2016-05-13

Outcome

Missed primary endpoint

registry analysis (unspecified test); PF-06669571 0.5 mg vs Placebo; p = 0.6382; Least Square Mean Difference -5.02; Mixed Models Analysis NCT02565628 ↗

paper The primary pharmacodynamic endpoint did not meet the pre-specified criteria for significant improvement PMID 29478239 ↗

Publications

Gurrell R, Duvvuri S, Sun P, DeMartinis N. A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Novel Dopamine D1 Receptor Partial Agonist, PF-06669571, in Subjects with Idiopathic Parkinson's Disease. Clin Drug Investig. 2018 Jun;38(6):509-517. doi: 10.1007/s40261-018-0632-6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	RAZPIPADON	Small molecule	3 mg	—