A Double Blind (3rd Party Open) Randomized, Placebo Controlled, Parallel Group Dose Escalation Study To Investigate The Safety, Toleration And Pharmacokinetics Of Multiple Oral Doses Of Pf-04895162 In Healthy Subjects

Pfizer1 site in 1 country10 target enrollmentOctober 2012

ConditionsHealthy

InterventionsPF-04895162 Placebo

DrugsPF-04895162 Placebo

Overview

Phase: Phase 1
Intervention: PF-04895162
Conditions: Healthy
Sponsor: Pfizer
Enrollment: 10
Locations: 1
Primary Endpoint: Maximum observed plasma concentration (Cmax)
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study in healthy people is to investigate safety, toleration and time course of plasma concentration of PF-04895162, following multiple oral doses for 14 days. The preliminary effect of food on Pharmacokinetics (PK) after single oral dose of PF-04895162 will also be investigated.

Registry

clinicaltrials.gov

Start Date

October 2012

End Date

March 2013

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy male and/or female subjects of non-child bearing 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).
•Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
•An informed consent document signed and dated by the subject.
•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).
•Any condition possibly affecting drug absorption (eg, gastrectomy).
•A positive urine drug screen.
•History of regular alcohol consumption exceeding 7 drinks/week for females or 14 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, whichever is longer) or 5 half lives preceding the first dose of study medication.
•Screening supine blood pressure \>=140 mm Hg (systolic) or \>=90 mm Hg (diastolic), on a single measurement (confirmed per local SOP) .
•12 lead ECG demonstrating QTc \>450 or a QRS interval \>120 msec at Screening. 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 values should be used to determine the subject's eligibility.
•Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study medication. As an exception, acetaminophen/paracetamol may be used at doses of \<=1 g/day. Limited use of non prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.
•Herbal supplements and hormonal methods of contraception (including oral and transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs and postcoital contraceptive methods) and hormone replacement therapy must be discontinued at least 28 days prior to the first dose of study medication.
•Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to dosing.