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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02373072

Enrollment

Registered

2015-02-26

Start date

2015-03-31

Completion date

2016-03-31

Last updated

2023-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Parkinson Disease

Keywords

Pakinson's Disease, Movement Disorders

Brief 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.

Interventions

DRUGPF-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.

DRUGTrimethobenzamide Hydrochloride

300mg TID, Capsules. Optional in both Cohorts.

DRUGPlacebo

Subjects completing all three treatment periods will be receiving placebo once.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

30 Years to 85 Years

Healthy volunteers

Inclusion criteria

* L-DOPA-responsiveness * Hoehn & Yahr Stage II-III inclusive * Experiencing motor fluctuations * Stable daily dose of L-DOPA of at least 300 mg * Females on non-childbearing potential and male subjects

Exclusion criteria

* History of troublesome dyskinesias * History of surgical intervention for Parkinson's disease

Design outcomes

Primary

Measure	Time frame
Number and proportion of subjects with Adverse Events (AEs)	Day 1 through 61
Number of participants with vital signs data that meet criteria of potential clinical concern	Day 1 through 61
Number of participants with ECG data that meet criteria of potential clinical concern	Day 1 through 61
Number of participants with abnormal clinically significant laboratory measurements	Day 1 through 61
C-SSRS (suicidality assessment)	Day 1 through 61

Secondary

Measure	Time frame	Description
MDS-UPDRS part III	Day 1, Periods 1-3	MDS - Unified Parkinson's Disease Rating Scale Part III

Countries

Belgium, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026