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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Idiopathic Parkinson Disease

Treatments: Drug: PF-06649751; Drug: Placebo; Drug: Trimethobenzamide Hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT02373072

B7601009

2014-004389-54 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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18 participants in 2 patient groups

Cohort 1

Experimental group

Description:

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.

Treatment:

Drug: PF-06649751

Drug: Placebo

Drug: Trimethobenzamide Hydrochloride

Cohort 2

Experimental group

Description:

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.

Treatment:

Drug: PF-06649751

Drug: Placebo

Drug: Trimethobenzamide Hydrochloride