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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: 80 mg PF-06473871; Drug: 160 mg PF-06473871; Drug: 320 mg PF-06473871; Drug: 480 mg PF-06473871

• Registration Number: NCT01753791
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-20
• Study First Submitted QC: 2012-12-17
• Study First Posted: 2012-12-20
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-24
• Last Update Posted: 2014-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

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

Exclusion Criteria

• Currently pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 1	80 mg PF-06473871	-
Cohort 2	160 mg PF-06473871	-
Cohort 3	320 mg PF-06473871	-
Cohort 4	480 mg PF-06473871	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pfizer Clinical Research Unit; 🇧🇪 Brussels, Belgium