A Clinical Study Evaluating The Safety And Tolerability Of PF-04427429 In Healthy Adult Volunteers. The Pharmacokinetics And Pharmacodynamics Of PF-04427429 Will Also Be Investigated

Phase 1

Completed

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

• Registration Number: NCT01165723
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04472429 administered intravenously to healthy adult volunteers.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-16
• Study First Submitted QC: 2010-07-16
• Study First Posted: 2010-07-20
• Study Start: 2010-08
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-21
• Last Update Posted: 2012-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 21

Inclusion Criteria

• Healthy male subjects between the ages of 18 and 50 years inclusive. (healthy is defined as non 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 50 to 100kg 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 haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, genitourinary, psychiatric, neurologic or allergic disease (including drug allergies, but excluding untreated symptomatic, seasonal allergies at time of dosing)
• History of febrile illness within 5 days prior to the first dose
• A positive urine drug screen

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV Dose 1: experimental	PF-04427429	-
IV Dose 2: experimental	PF-04427429	-

Primary Outcome Measures

Name	Time	Method
Safety (incidence/severity of adverse events and clinical laboratory abnormalities, mean change from baseline/placebo in vital signs/body temperature, mean change from baseline in 12 lead electrocardiogram parameters compared to baseline/placebo)	up to 129 days
Safety continued (categorical summary of QTcF compared to baseline between dose groups and placebo, concentration QTcF relationship, ADA responses, IV injection site reactions	up to 129 days
Pharmacokinetics (free plasma concentrations of PF-04427429 will be measured by a validated assay and non-compartmental PK parameters will be determined for each dose)	up to 129 days

Secondary Outcome Measures

Name	Time	Method
pharmacodynamics (free and total CGRP plasma concentration) will be measured, the PK-PD relationship between plasma PF-0447429 concentrations and free/total CGRP concentrations will be characterised	up to 129 days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Bruxelles, Belgium