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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01117233
First received: May 3, 2010
Last updated: January 17, 2012
Last verified: January 2012
  Purpose

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


Condition Intervention Phase
Healthy
Drug: PF-04427429
Phase 1

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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Adverse events, Vitals, ECG, laboratory safety tests, IV infusion site reaction [ Time Frame: up to 84 days ] [ Designated as safety issue: Yes ]
  • Plasma pharmacokinetics of PF-04427429 [ Time Frame: up to 84 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Free and total CGRP plasma concentrations [ Time Frame: up to 84 days ] [ Designated as safety issue: No ]
  • anti-drug antibody [ Time Frame: up to 84 days ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: May 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single IV Dose 1 Drug: PF-04427429
single intravenous infusion of 10 mg PF-04427429 or placebo
Experimental: Single IV Dose 2 Drug: PF-04427429
single intravenous infusion of 30 mg PF-04427429 or placebo
Experimental: Single IV Dose 3 Drug: PF-04427429
single intravenous infusion of 100 mg PF-04427429 or placebo
Experimental: Single IV Dose 4 Drug: PF-04427429
single intravenous infusion of 300 mg PF-04427429 or placebo
Experimental: Single IV Dose 5 Drug: PF-04427429
single intravenous infusion of 1000 mg PF-04427429 or placebo

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01117233

Locations
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1070
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01117233     History of Changes
Other Study ID Numbers: B0141002
Study First Received: May 3, 2010
Last Updated: January 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Healthy volunteers
PK
PD
safety and toleration

ClinicalTrials.gov processed this record on November 20, 2014