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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PF-04427429

• Registration Number: NCT01117233
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-03
• Study First Submitted QC: 2010-05-03
• Study First Posted: 2010-05-05
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-17
• Last Update Posted: 2012-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single IV Dose 1	PF-04427429	-
Single IV Dose 2	PF-04427429	-
Single IV Dose 3	PF-04427429	-
Single IV Dose 4	PF-04427429	-
Single IV Dose 5	PF-04427429	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Free and total CGRP plasma concentrations	up to 84 days
anti-drug antibody	up to 84 days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Bruxelles, Belgium