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

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

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: PF-04427429
* Drug: PF-04427429
* Drug: PF-04427429
* Drug: PF-04427429
* Drug: PF-04427429


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy volunteers, PK, PD, safety and toleration