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

Phase 1

Completed

• Conditions: Idiopathic Parkinson Disease
• Interventions: Drug: PF-06649751; Drug: Trimethobenzamide Hydrochloride; Drug: Placebo

• Registration Number: NCT02373072
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-20
• Study First Submitted QC: 2015-02-20
• Study First Posted: 2015-02-26
• Study Start: 2015-03
• Primary Completion: 2016-02
• Study Completion: 2016-03
• Status Verified: 2017-01
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 2	Trimethobenzamide Hydrochloride	Three single doses over three periods. For each of the three periods, subjects will be crossed-over from placebo or PF-06649751. Each PF-06649751 dose is separated by at least one week.
Cohort 1	Placebo	Three single doses over three periods. For each of the three periods, subjects will be crossed-over from placebo or PF-06649751. Each PF-06649751 dose is separated by at least one week.
Cohort 2	Placebo	Three single doses over three periods. For each of the three periods, subjects will be crossed-over from placebo or PF-06649751. Each PF-06649751 dose is separated by at least one week.
Cohort 1	Trimethobenzamide Hydrochloride	Three single doses over three periods. For each of the three periods, subjects will be crossed-over from placebo or PF-06649751. Each PF-06649751 dose is separated by at least one week.
Cohort 2	PF-06649751	Three single doses over three periods. For each of the three periods, subjects will be crossed-over from placebo or PF-06649751. Each PF-06649751 dose is separated by at least one week.
Cohort 1	PF-06649751	Three single doses over three periods. For each of the three periods, subjects will be crossed-over from placebo or PF-06649751. Each PF-06649751 dose is separated by at least one week.

Primary Outcome Measures

Name	Time	Method
Number of participants with abnormal clinically significant laboratory measurements	Day 1 through 61
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
C-SSRS (suicidality assessment)	Day 1 through 61

Secondary Outcome Measures

Name	Time	Method
MDS-UPDRS part III	Day 1, Periods 1-3	MDS - Unified Parkinson's Disease Rating Scale Part III

Trial Locations

Locations (8)

Walnut Hill Medical Center; 🇺🇸 Dallas, Texas, United States

Collaborative Neuroscience Network, LLC.; 🇺🇸 Long Beach, California, United States

Parkinson's Movement Disorder Center of Maryland; 🇺🇸 Elkridge, Maryland, United States

Pfizer Clinical Research Unit; 🇧🇪 Brussels, Belgium

SNBL Clinical Pharmacology Center, Inc.; 🇺🇸 Baltimore, Maryland, United States

Atlanta Center for Medical Research; 🇺🇸 Atlanta, Georgia, United States

MD Clinical; 🇺🇸 Hallandale Beach, Florida, United States

Neurology Consultants of Dallas, PA; 🇺🇸 Dallas, Texas, United States