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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: PF-04427429; Drug: PF-04427429; Drug: PF-04427429

Detailed Description

Phase 1 clinical trial

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy male subjects between the ages of 18 and 50 years, inclusive (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.
• Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Willing and able to comply with the requirement for using the recommended highly effective contraceptive methods throughout the study.

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 (eg, gastrectomy).
• History of febrile illness within 5 days prior to the first dose.
• A positive urine drug screen

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single IV Dose 1	Drug: PF-04427429; Single 0.2mg dose of intravenous infusion; Drug: PF-04427429; Single 1mg dose of intravenous infusion; Drug: PF-04427429; Single 3 mg dose of intravenous infusion
Experimental: Single IV Dose 2	Drug: PF-04427429; Single 0.2mg dose of intravenous infusion; Drug: PF-04427429; Single 1mg dose of intravenous infusion; Drug: PF-04427429; Single 3 mg dose of intravenous infusion
Experimental: Single IV Dose 3	Drug: PF-04427429; Single 0.2mg dose of intravenous infusion; Drug: PF-04427429; Single 1mg dose of intravenous infusion; Drug: PF-04427429; Single 3 mg dose of intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)	anticipated time is up to 84 days post dose
Safety continued (categorical summary of QTcF compared to baseline between dose groups and placebo, concentration QTcF relationship, ADA responses, IV injection site reactions)	anticipated time is up to 84 days post dose to 84 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)	anticipated time is up to 84 days post dose days

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacodynamics (free and total CGRP plasma concentrations will be measured, the PK-PD relationship between plasma PF-04427429 concentrations and free/total CGRP concentrations will be characterized)	anticipated time is up to 84 days

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: November 10, 2009
• First Submitted That Met QC Criteria: November 10, 2009
• First Posted (Estimate): November 11, 2009

Study Record Updates

• Last Update Posted (Actual): December 4, 2018
• Last Update Submitted That Met QC Criteria: November 30, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: B0141001