Clinical trial NCT02184429: 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
Official title: A Phase 1, Double Blind, Sponsor Open, Placebo Controlled Combined Single And Multiple Ascending Dose Study To Investigate The Safety, Tolerability And Food Effect On Pharmacokinetics Of PF-06669571 Following Oral Doses In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: First in human
single ascending dose study
multiple ascending dose study
safety and tolerability
pharmacokinetics
food effect
Parkinson's Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-07-09
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: Inclusion Criteria:

* 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:

1. 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;
2. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
3. 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: screening,Day 28
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) after single dose
timeFrame: 0-Day 5
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) after single dose
timeFrame: 0-Day 5
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] after single dose
timeFrame: 0-Day 5
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) after single dose
timeFrame: 0-Day 5
measure: Plasma Decay Half-Life (t1/2) after single dose
timeFrame: 0-Day 5
measure: Apparent Oral Clearance (CL/F) after single dose
timeFrame: 0-Day 5
measure: Apparent Volume of Distribution (Vz/F) after single dose
timeFrame: 0-Day 5
measure: Maximum Observed Plasma Concentration (Cmax) on Days 1, 7 and 14 after multiple daily dose
timeFrame: 0-Day 18
measure: Area Under the Curve from Time Zero to end of dosing interval (AUCtau) on days 1,7,14 after multiple daily doses
timeFrame: 0-Day 18
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) on days 1,7 14 after multiple daily doses
timeFrame: 0-Day 18
measure: Apparent Oral Clearance (CL/F) on day 7 and 14 after multiple daily doses
timeFrame: 0-Day 18
measure: Pre dose concentrations (Ctrough) on days 7 and 14 after multiple daily doses
timeFrame: 0-Day 18
measure: Minimum Observed Plasma Trough Concentration (Cmin) on days 7 and 14 after multiple daily doses
timeFrame: 0-Day 18
measure: Accumulation ratio (Rac) for AUCtau on days 7 and 14 after multiple daily doses
timeFrame: 0-day 18
measure: Accumulation ratio (Rac) for Cmax on days 7 and 14 after multiple daily doses
timeFrame: 0-Day 18
measure: Plasma Decay Half-Life (t1/2) on day 14 after multiple daily doses
timeFrame: 0-Day 18
measure: Apparent Volume of Distribution (Vz/F) on day 14 after multiple daily doses
timeFrame: 0-Day 18
measure: Renal clearance (CLr) on day 14
timeFrame: 0-Day 18
measure: Amount of unchanged drug recovered in urine during the dosing interval (AEtau) on Day 14 after multiple daily doses
timeFrame: 0-Day 18
measure: Percent of dose recovered unchanged in urine during the dosing interval (AEtau%) on Day 14 after multiple daily doses
timeFrame: 0-Day 18
measure: Peak to Trough ratio at Steady State (PTR)
timeFrame: 0-Day 18
Other outcomes:
Locations:
city: New Haven
country: United States
facility: New Haven Clinical Research Unit
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: