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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01753791

Enrollment

Registered

2012-12-20

Start date

2012-11-30

Completion date

2013-06-30

Last updated

2014-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

Interventions

DRUG80 mg PF-06473871

80 mg of PF-06473871 or placebo

DRUG160 mg PF-06473871

160 mg of PF-06473871 or placebo

DRUG320 mg PF-06473871

320 mg of PF-06473871 or placebo

DRUG480 mg PF-06473871

480 mg of PF-06473871 or placebo

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* Currently pregnant

Design outcomes

Primary

Measure	Time frame	Description
severity 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
Blood pressure	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
pulse rate	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.
Incidence of Adverse events	6 weeks	will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects

Secondary

Measure	Time frame	Description
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.
Maximum Observed Plasma Concentration (Cmax)	6 weeks	—
Time to Reach Maximum Observed Plasma Concentration (Tmax)	6 weeks	—

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026