Study In Healthy Adult Volunteers To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429

January 17, 2012 updated by: Pfizer

A Randomised, Placebo Controlled, Double-Blind, Third Party Open, Parallel Group Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429 Administered Intravenously To Healthy Adult Volunteers

The purpose is to study the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04427429 administered intravenously to healthy adult volunteers

Study Overview

Status

Completed

Conditions

Healthy

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Belgium
- - Bruxelles, Belgium, 1070
    - Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Healthy male subjects between the ages of 18 and 50 years inclusive (unless local regulations dictate a minimum age of 21 years). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests.
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight of between 50 kg and 100 kg inclusive.
Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.

Exclusion Criteria:

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, genitourinary, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, symptomatic, seasonal allergies at time of dosing).
Any condition possibly affecting drug absorption.
12-lead ECG demonstrating QTcF >450 msec at Screening. If QTcF exceeds 450 msec, the ECG should be repeated two more times and the average of the three QTcF values should be used to determine the subject's eligibility.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single IV Dose 1	Drug: PF-04427429 single intravenous infusion of 10 mg PF-04427429 or placebo Drug: PF-04427429 single intravenous infusion of 30 mg PF-04427429 or placebo Drug: PF-04427429 single intravenous infusion of 100 mg PF-04427429 or placebo Drug: PF-04427429 single intravenous infusion of 300 mg PF-04427429 or placebo Drug: PF-04427429 single intravenous infusion of 1000 mg PF-04427429 or placebo
Experimental: Single IV Dose 2	Drug: PF-04427429 single intravenous infusion of 10 mg PF-04427429 or placebo Drug: PF-04427429 single intravenous infusion of 30 mg PF-04427429 or placebo Drug: PF-04427429 single intravenous infusion of 100 mg PF-04427429 or placebo Drug: PF-04427429 single intravenous infusion of 300 mg PF-04427429 or placebo Drug: PF-04427429 single intravenous infusion of 1000 mg PF-04427429 or placebo
Experimental: Single IV Dose 3	Drug: PF-04427429 single intravenous infusion of 10 mg PF-04427429 or placebo Drug: PF-04427429 single intravenous infusion of 30 mg PF-04427429 or placebo Drug: PF-04427429 single intravenous infusion of 100 mg PF-04427429 or placebo Drug: PF-04427429 single intravenous infusion of 300 mg PF-04427429 or placebo Drug: PF-04427429 single intravenous infusion of 1000 mg PF-04427429 or placebo
Experimental: Single IV Dose 4	Drug: PF-04427429 single intravenous infusion of 10 mg PF-04427429 or placebo Drug: PF-04427429 single intravenous infusion of 30 mg PF-04427429 or placebo Drug: PF-04427429 single intravenous infusion of 100 mg PF-04427429 or placebo Drug: PF-04427429 single intravenous infusion of 300 mg PF-04427429 or placebo Drug: PF-04427429 single intravenous infusion of 1000 mg PF-04427429 or placebo
Experimental: Single IV Dose 5	Drug: PF-04427429 single intravenous infusion of 10 mg PF-04427429 or placebo Drug: PF-04427429 single intravenous infusion of 30 mg PF-04427429 or placebo Drug: PF-04427429 single intravenous infusion of 100 mg PF-04427429 or placebo Drug: PF-04427429 single intravenous infusion of 300 mg PF-04427429 or placebo Drug: PF-04427429 single intravenous infusion of 1000 mg PF-04427429 or placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse events, Vitals, ECG, laboratory safety tests, IV infusion site reaction Time Frame: up to 84 days	up to 84 days
Plasma pharmacokinetics of PF-04427429 Time Frame: up to 84 days	up to 84 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Free and total CGRP plasma concentrations Time Frame: up to 84 days	up to 84 days
anti-drug antibody Time Frame: up to 84 days	up to 84 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

May 3, 2010

First Submitted That Met QC Criteria

May 3, 2010

First Posted (Estimate)

May 5, 2010

Study Record Updates

Last Update Posted (Estimate)

January 18, 2012

Last Update Submitted That Met QC Criteria

January 17, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

B0141002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study In Healthy Adult Volunteers To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429

A Randomised, Placebo Controlled, Double-Blind, Third Party Open, Parallel Group Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429 Administered Intravenously To Healthy Adult Volunteers

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Clinical Trials on Healthy

Clinical Trials on PF-04427429

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