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

Pfizer18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Idiopathic Parkinson Disease

Interventions

PF-06649751DRUG

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.

Trimethobenzamide HydrochlorideDRUG

300mg TID, Capsules. Optional in both Cohorts.

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 30 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (8)

Collaborative Neuroscience Network, LLC.

Long Beach, California, United States

MD Clinical

Hallandale, Florida, United States

Atlanta Center for Medical Research

Atlanta, Georgia, United States

SNBL Clinical Pharmacology Center, Inc.

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Number and proportion of subjects with Adverse Events (AEs)

Time frame: Day 1 through 61

Number of participants with vital signs data that meet criteria of potential clinical concern

Time frame: Day 1 through 61

Number of participants with ECG data that meet criteria of potential clinical concern

Time frame: Day 1 through 61

Number of participants with abnormal clinically significant laboratory measurements

Time frame: Day 1 through 61

C-SSRS (suicidality assessment)

Time frame: Day 1 through 61

Secondary Outcomes

MDS-UPDRS part III

MDS - Unified Parkinson's Disease Rating Scale Part III

Time frame: Day 1, Periods 1-3

Data from ClinicalTrials.gov

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