drugset / Trial / NCT02373072

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of PF-06649751 in Subjects With Idiopathic Parkinson's Disease

NCT02373072

Phase 1 Completed 18 enrolled Pfizer
RandomizedParallel-groupDouble-blindBasic science

Summary

This is a study with two sequential cohorts, each with three treatment periods. Single doses of PF-06649751 will be tested in this study, starting at a low dose and escalating to a dose projected to be under the current limits for drug concentration. Each cohort will aim to achieve approximately 9 completers. Primary endpoint is safety and tolerability, secondary endpoint is MDS-UPDRS part III.

Timeline

Start
2015-03
Primary completion
2016-02
Completion
2016-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Tavapadon Small molecule 0.75 mg
Subject Tavapadon Small molecule 1.5 mg
Subject Tavapadon Small molecule 3 mg
Subject Tavapadon Small molecule 6 mg
Subject Tavapadon Small molecule 9 mg
Background Trimethobenzamide Small molecule 300 mg

Indications