NCT02373072

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

A Phase 1, Double Blind, Sponsor Open, Randomized, Placebo-controlled, Single Ascending Dose Study To Investigate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06649751 In Subjects With Idiopathic Parkinson's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Idiopathic Parkinson Disease

Interventions

Type	Name	Description
DRUG	PF-06649751	Subjects completing all three treatment periods will be administered two doses. Doses: 0.75mg, 1.5mg, 3mg, 6mg, 9mg. Tablets in the form of 0.25mg or 1 mg.
DRUG	Trimethobenzamide Hydrochloride	300mg TID, Capsules. Optional in both Cohorts.
DRUG	Placebo	Subjects completing all three treatment periods will be receiving placebo once.

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-02-01
• Completion: 2016-03-01
• First posted: 2015-02-26
• Last updated: 2023-09-22

Locations

8 sites across 2 countries: United States, Belgium