A Phase 1 Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03893787 In Healthy Adult Volunteers

A Double Blind (3rd Party Open), Randomised, Placebo-Controlled, Dose Escalation Study To Investigate The Safety, Toleration, And Pharmacokinetics Of Multiple Oral Doses Of PF-03893787 In Healthy Subjects

The purpose of this study is to investigate safety and toleration of multiple oral doses as well as the time course of PF-03893787 concentration in the blood following dosing by oral solution.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: PF-03893787; Drug: PF-03893787; Drug: PF-03893787

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, 1070
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male subjects and females of non-childbearing potential between the ages of 18 and 55 years.
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m^2; and a total body weight >50 kg (110 lbs).

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).
• A positive urine drug screen.
• History of regular alcohol consumption exceeding 21 drinks/week for males and 14 drinks/week for females.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PF-03893787 5 mg	Drug: PF-03893787; oral solution, 5 mg, QD for 14 days; Drug: PF-03893787; oral solution, 15 mg, QD for 14 days; Drug: PF-03893787; oral solution, 50 mg, QD for 14 days
Experimental: PF-03893787 15 mg	Drug: PF-03893787; oral solution, 5 mg, QD for 14 days; Drug: PF-03893787; oral solution, 15 mg, QD for 14 days; Drug: PF-03893787; oral solution, 50 mg, QD for 14 days
Experimental: PF-03893787 50 mg	Drug: PF-03893787; oral solution, 5 mg, QD for 14 days; Drug: PF-03893787; oral solution, 15 mg, QD for 14 days; Drug: PF-03893787; oral solution, 50 mg, QD for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety/toleration: Adverse events, vital signs, 12 lead ECG, blood (including creatine kinase) and urine safety tests and physical examination.	22 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic parameters: Cmax, Tmax, AUCτ, t½, accumulation ratio,	22 days

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: October 8, 2009
• First Submitted That Met QC Criteria: October 8, 2009
• First Posted (Estimate): October 9, 2009

Study Record Updates

• Last Update Posted (Estimate): March 18, 2010
• Last Update Submitted That Met QC Criteria: March 17, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Other Study ID Numbers: B0281003