Clinical Trials/NCT02539550

NCT02539550

Completed

Phase 1

A Phase 1, Placebo-controlled, Randomized, Subject- And Investigator-blind, Sponsor-open, Crossover Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Pf-06266047 After Administration Of Single Ascending Doses To Healthy Adult Subjects

Pfizer1 site in 1 country25 target enrollmentAugust 2015

ConditionsHealthy Volunteers

InterventionsPlacebo PF-06266047

DrugsPlacebo PF-06266047

Overview

Phase: Phase 1
Intervention: Placebo
Conditions: Healthy Volunteers
Sponsor: Pfizer
Enrollment: 25
Locations: 1
Primary Endpoint: Number of participants with Adverse Events (AEs)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of PF-06266047 after first-time administration to healthy adult subjects.

Registry

clinicaltrials.gov

Start Date

August 2015

End Date

May 2016

Last Updated

9 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy female subjects of non-childbearing potential and/or male subjects who, at the time of screening, are 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 or 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) 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 all scheduled visits, treatment plan, laboratory tests, and other study procedures.
•Subject must be willing to avoid direct sunlight exposure or any high intensity ultraviolet light exposure, from the first day of dosing with study medication and until the follow-up visit; and to apply sun cream/lotion with a high sun protection factor, as appropriate.

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 the time of dosing).
•Any condition possibly affecting drug absorption (eg, gastrectomy).
•A positive urine drug screen.
•History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (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 of 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 study medication (whichever is longer).
•Screening supine blood pressure \>140 mm Hg (systolic) or \>90 mm Hg (diastolic), following at least 5 minutes of supine rest. If blood pressure (BP) is \>140 mm Hg (systolic) or \>90 mm Hg (diastolic), the BP should be repeated two more times and the average of the three BP values should be used to determine the subject's eligibility.
•Screening supine 12-lead ECG demonstrating QTc \>450 msec or a QRS interval \>120 msec. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc or QRS values should be used to determine the subject's eligibility.
•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, if deemed necessary:
•Aspartate aminotransferase (AST)/serum glutamic oxaloacetic aminotransferase (SGOT) or alanine aminotransferase (ALT)/serum glutamic pyruvic aminotransferase (SGPT) \>1.5 x upper limit of normal (ULN);
•Total bilirubin \>1.5 x ULN; subjects with a history of Gilbert's syndrome may have a direct bilirubin measured and would be eligible for this study provided the direct bilirubin is \<ULN.

Arms & Interventions

Placebo

Intervention: Placebo

PF-06266047

Intervention: PF-06266047

Outcomes

Primary Outcomes

Number of participants with Adverse Events (AEs)

Time Frame: Baseline up to 1 day of dosing

Number of participants with AEs occurring after first dose of study drug. Relatedness to study drug will be assessed by investigator.

Orthostatic blood pressure and pulse rate

Time Frame: 0, 1, 2, 4, 8, 12, 24, 48, and 72 hours post-dose

Absolute values and changes from baseline for blood pressure and pulse rate

Abnormal rhythms as observed on continuous cardiac telemetry

Time Frame: Baseline period of at least 2 hours and continuous tracing for at least 8 hours following single dose administration

All abnormal rhythms will be reviewed by the study physician for the presence of rhythms of potential clinical concern. The time, duration and description of any clinically significant event will be recorded.

Electrocardiogram (ECG)

Time Frame: 0, 1, 2, 4, 8, 12, 24, 48, and 72 hours post-dose

Absolute values and changes from baseline for the ECG parameters

Number of subjects with standard safety laboratory test results of potential clinical significance

Time Frame: Baseline up to 1 day of dosing

Number of subjects with standard safety laboratory test results of potential clinical significance (according to pre-defined criteria).

Secondary Outcomes

Maximum Observed Plasma Concentration (Cmax)(0, 0.5, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose)
Time to Reach Maximum Observed Plasma Concentration (Tmax)(0, 0.5, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(0, 0.5, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose)
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)](0, 0.5, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose)
Plasma Decay Half-Life (t1/2)(0, 0.5, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose)
Apparent Oral Clearance (CL/F)(0, 0.5, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose)
Apparent Volume of Distribution (Vz/F)(0, 0.5, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose)