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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01753791
• Other study ID #: B5301002
• Secondary ID: 2012-003797-13
• Status: Completed
• Phase: Phase 1
• First received: November 20, 2012
• Last updated: September 24, 2014
• Start date: November 2012
• Est. completion date: June 2013

Study information

• Verified date: September 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Currently pregnant

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• 80 mg PF-06473871
80 mg of PF-06473871 or placebo
• 160 mg PF-06473871
160 mg of PF-06473871 or placebo
• 320 mg PF-06473871
320 mg of PF-06473871 or placebo
• 480 mg PF-06473871
480 mg of PF-06473871 or placebo

Locations

Country	Name	City	State
Belgium	Pfizer Clinical Research Unit	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse events	will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects	6 weeks	Yes
Primary	ECGs	will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects	6 weeks	Yes
Primary	Blood pressure	will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects	6 weeks	Yes
Primary	pulse rate	will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects	6 weeks	Yes
Primary	Injection siter reaction	The number and percentage of subjects that experienced injection site reactions will be analyzed.	6 weeks	No
Primary	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	Yes
Primary	severity of adverse events	will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects	6 weeks	Yes
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax)		6 weeks	No
Secondary	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	No
Secondary	Maximum Observed Plasma Concentration (Cmax)		6 weeks	No

External Links

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