PF-06669571 In Subjects With Idiopathic Parkinson's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 2 August 2023
• Main ID: NCT02565628
• Date of registration: 28/09/2015
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: PF-06669571 In Subjects With Idiopathic Parkinson's Disease
• Scientific 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.
• Date of first enrolment: November 16, 2015
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02565628
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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.



Age minimum: 45 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Parkinson's Disease

Intervention(s)

Drug: PF-06669571

Drug: Placebo

Primary Outcome(s)

Number of Participants With Laboratory Abnormalities That Met Categorical Criteria for Concern (Without Regard to Baseline Abnormality) [Time Frame: Screening, Days 1, 4, and 7, and follow-up visit]

Number of Participants With Supine and Standing Vital Sign Abnormalities of Potential Clinical Concern (Absolute Values) [Time Frame: Screening, Days -1, 1, 7 and 8, and follow-up visit]

Number of Participants With New Onset and Worsening of Post-Baseline Suicidality. [Time Frame: Day 8 or follow-up visit (Day 7 - 14 after last dose of PF-06669571)]

Number of Participants With Supine and Standing Vital Sign Abnormalities of Potential Clinical Concern (Increase From Baseline) [Time Frame: Screening, Days -1, 1, 7 and 8, and follow-up visit]

Number of Participants With Supine and Standing Vital Sign Abnormalities (Decrease From Baseline) [Time Frame: Screening, Days -1, 1, 7 and 8, and follow-up visit]

Number of Participants With Treatment Emergent Adverse Events (All Causalities) [Time Frame: Day 1 to 28 calendar days after the last dose of investigational product]

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 [Time Frame: Day -2, Day 8, and follow-up visit (Day 7 - 14 after last dose of PF-06669571)]

Number of Participants With Electrocardiogram (ECG) That Met Categorical Criteria for Concern (Absolute Value) [Time Frame: Screening, Days 1, 7, and 8, and follow-up visit]

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. [Time Frame: Day 7]

Primary: Number of Participants With Electrocardiogram (ECG) That Met Categorical Criteria for Concern(Increase From Baseline) [Time Frame: Screening, Days 1, 7, and 8, and follow-up visit]

Secondary Outcome(s)

Area Under Curve From Time Zero to 24 Hours (AUC24) of PF-06669571 on Day 7 [Time Frame: 0, 1, 3, 5, 8, 12 and 24 hours post-dose on Day 7]

Maximum Observed Plasma Concentration (Cmax) of PF-06669571 on Day 1 and Day 7 [Time Frame: 0, 1, 3, 5, 8 and 12 hours post-dose on both Day 1 and Day 7]

Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06669571 on Day 1 and Day 7 [Time Frame: 0, 1, 3, 5, 8 and 12 hours post-dose on both Day 1 and Day 7]

Area Under Curve From Time Zero to 12 Hours (AUC12) of PF-06669571 on Day 1 and Day 7 [Time Frame: 0, 1, 3, 5, 8 and 12 hours post-dose on both Day 1 and Day 7]

Secondary ID(s)

B7821002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 07/08/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02565628