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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01011296
First received: November 10, 2009
Last updated: May 14, 2010
Last verified: May 2010
  Purpose

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


Condition Intervention Phase
Healthy Volunteers
Drug: PF-04427429
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: 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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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) [ Time Frame: anticipated time is up to 84 days post dose ] [ Designated as safety issue: Yes ]
  • Safety continued (categorical summary of QTcF compared to baseline between dose groups and placebo, concentration QTcF relationship, ADA responses, IV injection site reactions) [ Time Frame: anticipated time is up to 84 days post dose to 84 days ] [ Designated as safety issue: Yes ]
  • 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) [ Time Frame: anticipated time is up to 84 days post dose days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) [ Time Frame: anticipated time is up to 84 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: December 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single IV Dose 1 Drug: PF-04427429
Single 0.2mg dose of intravenous infusion
Experimental: Single IV Dose 2 Drug: PF-04427429
Single 1mg dose of intravenous infusion
Experimental: Single IV Dose 3 Drug: PF-04427429
Single 3 mg dose of intravenous infusion

Detailed Description:

Phase 1 clinical trial

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01011296

Locations
United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85013
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01011296     History of Changes
Other Study ID Numbers: B0141001
Study First Received: November 10, 2009
Last Updated: May 14, 2010
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 15, 2014