Study To Evaluate Safety, Tolerability, And Pharmacokinetics Of PF-06473871 In Normal Healthy Adults

A Phase 1, Dose Expansion Of A Within-cohort, Randomized, Double-blind, Third-party Open, Placebo-controlled, Single-and Multiple-dose Escalation Study To Evaluate Safety, Tolerability, And Pharmacokinetics Of Pf-06473871 In Normal Healthy Adults

The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of PF-06473871 in normal healthy adults.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: 80 mg PF-06473871; Drug: 160 mg PF-06473871; Drug: 320 mg PF-06473871; Drug: 480 mg PF-06473871

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, B-1070
    • Pfizer Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male and/or females between the ages of 18 and 55 years inclusive

Exclusion Criteria:

• Currently pregnant

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1	Drug: 80 mg PF-06473871; 80 mg of PF-06473871 or placebo
Experimental: Cohort 2	Drug: 160 mg PF-06473871; 160 mg of PF-06473871 or placebo
Experimental: Cohort 3	Drug: 320 mg PF-06473871; 320 mg of PF-06473871 or placebo
Experimental: Cohort 4	Drug: 480 mg PF-06473871; 480 mg of PF-06473871 or placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse events	will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects	6 weeks
ECGs	will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects	6 weeks
Blood pressure	will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects	6 weeks
pulse rate	will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects	6 weeks
Injection siter reaction	The number and percentage of subjects that experienced injection site reactions will be analyzed.	6 weeks
number of subjects with adverse events	will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects	6 weeks
severity of adverse events	will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Reach Maximum Observed Plasma Concentration (Tmax)		6 weeks
Area under the Concentration-Time Curve (AUC)	AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.	6 weeks
Maximum Observed Plasma Concentration (Cmax)		6 weeks

Collaborators and Investigators

• Sponsor: Pfizer

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: November 20, 2012
• First Submitted That Met QC Criteria: December 17, 2012
• First Posted (Estimate): December 20, 2012

Study Record Updates

• Last Update Posted (Estimate): September 26, 2014
• Last Update Submitted That Met QC Criteria: September 24, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: B5301002; 2012-003797-13 (EudraCT Number)