Clinical trial NCT02565628: PF-06669571 In Subjects With Idiopathic Parkinson's Disease
Official title: A Phase 1b, Double Blind, Sponsor Open, Randomized, Parallel, Group Multiple Dose Study Examining The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06669571 In Subjects With Idiopathic Parkinson's Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Idiopathic Parkinson's Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2015-10-01
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is designed to assess safety, tolerability and pharmacokinetic data for multiple doses of PF-06669571 in subjects with idiopathic Parkinson's disease. In addition, this study will assess whether PF-06669571 is able to demonstrate superior efficacy compared with placebo in the treatment of the motor symptoms of idiopathic Parkinson's disease.


Eligibility criteria: Inclusion Criteria:

* Subjects must have a clinical diagnosis of idiopathic Parkinson's disease and presence of at least 2 out of 3 cardinal characteristics (tremor, rigidity and/or bradykinesia).
* Must be Hoehn \& Yahr Stage II-III inclusive and experiencing motor fluctuations in the form of end-of-dose wearing off during the morning hours or early morning akinesia.
* Subjects should be able to recognize their "wearing off" symptoms and verify that they usually improve after their next dose of Parkinson's disease medication. Subjects should be able to recognize drug-induced dyskinesias and verify whether or not they are troublesome.

Exclusion Criteria:

- History or clinical features consistent with an atypical parkinsonian syndrome, (for example: ataxia, dystonia, clinically significant orthostatic hypotension.

Primary outcomes:
measure: Maximum Percent Change From Baseline in Movement Disorder Society-Sponsor Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III at Day 7.
timeFrame: Day 7
measure: Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category by Study Visit on Day -2, Day 8 or Early Withdrawal, and Early Withdrawal/Follow-Up Visit
timeFrame: Day -2, Day 8, and follow-up visit (Day 7 - 14 after last dose of PF-06669571)
measure: Number of Participants With New Onset and Worsening of Post-Baseline Suicidality.
timeFrame: Day 8 or follow-up visit (Day 7 - 14 after last dose of PF-06669571)
measure: Number of Participants With Treatment Emergent Adverse Events (All Causalities)
timeFrame: Day 1 to 28 calendar days after the last dose of investigational product
measure: Number of Participants With Supine and Standing Vital Sign Abnormalities of Potential Clinical Concern (Absolute Values)
timeFrame: Screening, Days -1, 1, 7 and 8, and follow-up visit
measure: Number of Participants With Supine and Standing Vital Sign Abnormalities of Potential Clinical Concern (Increase From Baseline)
timeFrame: Screening, Days -1, 1, 7 and 8, and follow-up visit
measure: Number of Participants With Supine and Standing Vital Sign Abnormalities (Decrease From Baseline)
timeFrame: Screening, Days -1, 1, 7 and 8, and follow-up visit
measure: Number of Participants With Electrocardiogram (ECG) That Met Categorical Criteria for Concern (Absolute Value)
timeFrame: Screening, Days 1, 7, and 8, and follow-up visit
measure: Primary: Number of Participants With Electrocardiogram (ECG) That Met Categorical Criteria for Concern(Increase From Baseline)
timeFrame: Screening, Days 1, 7, and 8, and follow-up visit
measure: Number of Participants With Laboratory Abnormalities That Met Categorical Criteria for Concern (Without Regard to Baseline Abnormality)
timeFrame: Screening, Days 1, 4, and 7, and follow-up visit
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of PF-06669571 on Day 1 and Day 7
timeFrame: 0, 1, 3, 5, 8 and 12 hours post-dose on both Day 1 and Day 7
measure: Area Under Curve From Time Zero to 12 Hours (AUC12) of PF-06669571 on Day 1 and Day 7
timeFrame: 0, 1, 3, 5, 8 and 12 hours post-dose on both Day 1 and Day 7
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06669571 on Day 1 and Day 7
timeFrame: 0, 1, 3, 5, 8 and 12 hours post-dose on both Day 1 and Day 7
measure: Area Under Curve From Time Zero to 24 Hours (AUC24) of PF-06669571 on Day 7
timeFrame: 0, 1, 3, 5, 8, 12 and 24 hours post-dose on Day 7
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer New Haven Clinical Research Unit
state: Connecticut
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: Hollywood
country: United States
facility: QPS-MRA, LLC (Broward Research Group)
state: Florida
city: South Miami
country: United States
facility: Qps-Mra Llc
state: Florida
city: South Miami
country: United States
facility: QPS-MRA, LLC (Miami research Associates)
state: Florida
city: South Miami
country: United States
facility: QPS-MRA, LLC (MRA Clinical Research)
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Marlton
country: United States
facility: CRI Worldwide, LLC
state: New Jersey
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Gurrell R, Duvvuri S, Sun P, DeMartinis N. A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Novel Dopamine D1 Receptor Partial Agonist, PF-06669571, in Subjects with Idiopathic Parkinson's Disease. Clin Drug Investig. 2018 Jun;38(6):509-517. doi: 10.1007/s40261-018-0632-6.