A Study To Understand Safety And Plasma Concentrations Of PF-06669571 During And Following The Oral Administration Of Single And Multiple Doses Of PF-06669571 In Healthy Volunteers Under Fasted And Fed Conditions

NCT02184429 | Completed Phase 1

• 1 other identifier: B7821001
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate the safety and plasma concentrations of PF-06669571 in healthy volunteers following single and multiple ascending doses of PF-06669571. Effect of food on PF-06669571 plasma concentrations will be be evaluated after a single dose of PF-06669571. During multiple dose phase, PF-06669571 will be administered daily for 14 days

Conditions

Healthy

Keywords

First in human; single ascending dose study; multiple ascending dose study; safety and tolerability; pharmacokinetics; food effect; Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)

  C-SSRS assessed whether participant experienced following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3)("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)("Yes" on "Has subject engaged in non-suicidal self-injurious behavior").

  screening,Day 28

Secondary Outcomes (21)

• Maximum Observed Plasma Concentration (Cmax) after single dose

  0-Day 5

• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) after single dose

  0-Day 5

• Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] after single dose

  0-Day 5

• Time to Reach Maximum Observed Plasma Concentration (Tmax) after single dose

  0-Day 5

• Plasma Decay Half-Life (t1/2) after single dose

  0-Day 5

Study Arms (7)

Single Ascending Dose-1

EXPERIMENTAL

Single ascending doses of PF-06669571 administered to healthy volunteers in a cross over study design

Drug: PF-06669571

Single Ascending Dose-2

EXPERIMENTAL

Single ascending doses of PF-06669571 administered to healthy volunteers in a cross over study design

Drug: PF-06669571

Multiple Ascending Dose-1

EXPERIMENTAL

Daily dose of PF-06669571 in healthy volunteers

Drug: PF-06669571

Multiple Ascending Dose-2

EXPERIMENTAL

Daily dose of PF-06669571 in healthy volunteers

Drug: PF-06669571

Multiple Ascending Dose-3

EXPERIMENTAL

Daily dose of PF-06669571 in healthy volunteers

Drug: PF-06669571

Multiple Ascending Dose-4

EXPERIMENTAL

Daily dose of PF-06669571 in healthy volunteers

Drug: PF-06669571

Multiple Ascending Dose-5

EXPERIMENTAL

Daily dose of PF-06669571 in healthy volunteers

Drug: PF-06669571

Interventions

PF-06669571 DRUG

Single ascending doses of PF-06669571 as extemporaneously prepared solution/suspension, once week in a cross over study: 0.2 mg 0.4 mg, 0.75 mg, 1.50 mg and placebo

Single Ascending Dose-1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
• Female subjects of non-childbearing potential must meet at least one of the following criteria:
• Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle-stimulating hormone (FSH) level confirming the post-menopausal state;
• Have undergone a documented hysterectomy and/or bilateral oophorectomy;
• Have medically confirmed ovarian failure. All other female subjects (including females with tubal ligations and females that do NOT have a documented hysterectomy, bilateral oophorectomy and/or ovarian failure) will be considered to be of childbearing potential.
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
• Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

You may not qualify if:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
• Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study medication (whichever is longer).
• Screening supine blood pressure \>= 140 mm Hg (systolic) or \>=90 mm Hg (diastolic), following at least 5 minutes of rest. If BP is \>=140 mm Hg (systolic) or \>=90 mm Hg (diastolic), repeat per local standard operating procedures (SOP). If orthostatic changes are present and deemed to be clinically significant by the investigator, Subject can be excluded.
• For subjects who answer "Yes" to the Columbia Suicide Severity Rating Scale (C-SSRS) questions 4 or 5, a risk assessment should be done by a qualified mental health professional (MHP: a psychiatrist or licensed PhD level clinical psychologist) to assess whether it is safe for the subject to participate in the study. In addition, subjects deemed by the investigator to be at significant risk of suicidal or violent behavior should be excluded.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Parkinson Disease

Interventions

PF-06669571

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative 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: July 3, 2014
• First Posted: July 9, 2014
• Study Start: July 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: September 6, 2018

Record last verified: 2016-03

Locations

US (1)