Clinical trial NCT03092232: Single Dose Study to Assess the Safety, Tolerability and Pharmacokinetics(PK) of PF-06865571
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Single Escalating Oral Doses Of Pf-06865571 In Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2017-03-27
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The current study is the first clinical trial proposed with PF-06865571. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of single doses of PF-06865571 to healthy adult subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy males and female of non-childbearing potential;
* Age of 18-55, inclusive;
* Body Mass Index 22.5 to 35.4 kg/m2, inclusive;
* Body weight \>50 kg;
* Not on any prescription or non-prescription drugs within 7 days or 5 half-lives prior to first dose.

Exclusion Criteria:

* Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergises, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive urine drug test.
* History of regular alcohol consumption exceeding 7 drinks/week for female subjects or 14 drinks/week for male subjects (1 drink = 5 ounces \[150 mL\] of wine or 12 ounces \[360 mL\] of beer or 1.5 ounces \[45 mL\] of hard liquor) within 6 months before screening.
* Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product (whichever is longer).
* Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
* Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
* History of sensitivity to heparin or heparin induced thrombocytopenia.
* History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb), or hepatitis C antibody (HCVAb).
* Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
* Subjects with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary: (1)Aspartate aminotransferase (AST), alanine aminotransferase (ALT) level, or total bilirubin \> upper limit of normal (ULN); (2) For optional Cohort 3 only, AST or ALT greater or equal to 1.5 × ULN, provided that data from Cohorts 1 and 2 support this limit; (3) • Subjects with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is less than or equal to ULN plus ALT and AST are less than or equal to ULN plus alkaline phosphatase, hemoglobin, and reticulocyte count are all less than or equal to ULN.
* Unwilling or unable to comply with the criteria in the Lifestyle Requirements section of this protocol.
* Subjects who are investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
* Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Primary outcomes:
measure: Number of subjects with adverse events (AEs)
timeFrame: Screening up to 35 days after last dose of study medication
measure: Number of subjects with laboratory tests findings of potential clinical importance
timeFrame: Baseline (Day 0) up to 14 days after last dose of study medication
measure: Number of subjects with vital signs findings of potential clinical importance
timeFrame: Baseline (Day 0) up to 14 days after last dose of study medication
measure: Number of subjects with electrocardiogram (ECG) findings of potential clinical importance
timeFrame: Baseline (Day 0) up to 14 days after last dose of study medication
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06865571
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post dose in each period
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time for PF-06865571
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post dose in each period
measure: Dose normalized AUClast for PF-06865571
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post dose in each period
measure: Dose normalized AUCinf for PF-06865571
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post dose in each period
measure: Maximum Observed Plasma Concentration (Cmax) for PF-06865571
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post dose in each period
measure: Dose normalized Cmax for PF-06865571
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post dose in each period
measure: Time to Reach Maximum Observed Concentration for PF-06865571
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post dose in each period
measure: Plasma Decay Half-Life (t1/2) for PF-06865571
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post dose in each period
measure: Apparent Oral Clearance (CL/F) for PF-06865571
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post dose in each period
measure: Apparent Volume of Distribution (Vz/F) for PF-06865571
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post dose in each period
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer New Haven Clinical Research Unit
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: