NCT02373072

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2015

Geographic Reach
2 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

September 22, 2023

Status Verified

January 1, 2017

Enrollment Period

11 months

First QC Date

February 20, 2015

Last Update Submit

September 20, 2023

Conditions

Idiopathic Parkinson Disease

Keywords

Pakinson's Disease, Movement Disorders

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (1)

  • MDS-UPDRS part III

    Day 1, Periods 1-3

Study Arms (2)

Cohort 1

EXPERIMENTAL

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.

Drug: PF-06649751Drug: Trimethobenzamide HydrochlorideDrug: Placebo

Cohort 2

EXPERIMENTAL

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.

Drug: PF-06649751Drug: Trimethobenzamide HydrochlorideDrug: Placebo

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.

Cohort 1Cohort 2
Trimethobenzamide HydrochlorideDRUG

300mg TID, Capsules. Optional in both Cohorts.

Cohort 1Cohort 2
PlaceboDRUG

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

Cohort 1Cohort 2

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Collaborative Neuroscience Network, LLC.

Long Beach, California, 90806, United States

Location

MD Clinical

Hallandale, Florida, 33009, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

SNBL Clinical Pharmacology Center, Inc.

Baltimore, Maryland, 21201, United States

Location

Parkinson's Movement Disorder Center of Maryland

Elkridge, Maryland, 21075, United States

Location

Neurology Consultants of Dallas, PA

Dallas, Texas, 75231, United States

Location

Walnut Hill Medical Center

Dallas, Texas, 75231, United States

Location

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Location

Related Publications (1)

  • Sohur US, Gray DL, Duvvuri S, Zhang Y, Thayer K, Feng G. Phase 1 Parkinson's Disease Studies Show the Dopamine D1/D5 Agonist PF-06649751 is Safe and Well Tolerated. Neurol Ther. 2018 Dec;7(2):307-319. doi: 10.1007/s40120-018-0114-z. Epub 2018 Oct 25.

    PMID: 30361858DERIVED

Related Links

MeSH Terms

Conditions

Parkinson DiseaseMovement Disorders

Interventions

trimethobenzamide

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2015

First Posted

February 26, 2015

Study Start

March 1, 2015

Primary Completion

February 1, 2016

Study Completion

March 1, 2016

Last Updated

September 22, 2023

Record last verified: 2017-01

Locations

BE(1)US(7)