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CompletedNCT01117233Updated Jan 18, 2012

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

A Phase 1 interventional study of PF-04427429 and PF-04427429 in Healthy, sponsored by Pfizer. Completed at 1 site in Belgium. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-01-18.

Sponsored by Pfizer · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy

Keywords

  • Healthy volunteers
  • PK
  • PD
  • safety and toleration
03

In context

Lead sponsor

Pfizer is the lead sponsor of 3,331 studies on the registry; 148 are open to participants now.

Of its 600 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Browse Pfizer studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Single IV Dose 1

    Drug: PF-04427429

  • Experimental
    Single IV Dose 2

    Drug: PF-04427429

  • Experimental
    Single IV Dose 3

    Drug: PF-04427429

  • Experimental
    Single IV Dose 4

    Drug: PF-04427429

  • Experimental
    Single IV Dose 5

    Drug: PF-04427429

Interventions

  • DrugPF-04427429

    single intravenous infusion of 10 mg PF-04427429 or placebo

  • DrugPF-04427429

    single intravenous infusion of 30 mg PF-04427429 or placebo

  • DrugPF-04427429

    single intravenous infusion of 100 mg PF-04427429 or placebo

  • DrugPF-04427429

    single intravenous infusion of 300 mg PF-04427429 or placebo

  • DrugPF-04427429

    single intravenous infusion of 1000 mg PF-04427429 or placebo

06

What researchers measure

Primary outcomes

  1. Adverse events, Vitals, ECG, laboratory safety tests, IV infusion site reaction

    Time frame: up to 84 days

  2. Plasma pharmacokinetics of PF-04427429

    Time frame: up to 84 days

Secondary outcomes

  1. Free and total CGRP plasma concentrations

    Time frame: up to 84 days

  2. anti-drug antibody

    Time frame: up to 84 days

07

Study locations

1 site
  • Pfizer Investigational Site
    Brussels, 1070, Belgium
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2010, a primary completion of Nov 2011 and a completion of Nov 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 3, 2010
First posted
May 5, 2010
Start
May 2010
Primary completionActual
Nov 2011
CompletionActual
Nov 2011
Last update
Jan 18, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 18, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01117233
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
May 5, 2010
Start date
May 2010
Primary completion
Nov 2011
Completion
Nov 2011
Last update
Jan 18, 2012

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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