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Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study Of PF-04427429 In Healthy Women Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01511497
First Posted: January 18, 2012
Last Update Posted: February 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-04427429 in healthy women.

Condition Intervention Phase
Pain Migraine Disorders Biological: PF-04427429 Other: Normal saline Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo Controlled, Double-Blind, Third Party Open, Ascending Dose Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429 Administered Intravenously To Healthy Female Adult Volunteers

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Screening up to Day 168 ]
  • Incidence and severity of clinical laboratory abnormalities. [ Time Frame: Screening up to Day 168 ]
  • Mean change from baseline and placebo in blood pressure (BP). [ Time Frame: Screening up to Day 168 ]
  • Mean change from baseline in 12-lead electrocardiogram (ECG) parameters compared to baseline and placebo. [ Time Frame: Screening up to Day 168 ]
  • Categorical summary of QTcF compared to baseline between dose groups and placebo. [ Time Frame: Screening up to Day 168 ]
  • Anti-Drug Antibodies (ADA) responses. [ Time Frame: From Day 0 up to Day 168 and until levels return to baseline. ]
  • Intravenous (IV) injection site reactions. [ Time Frame: Day 1 post dose ]
  • Mean change from baseline and placebo in pulse rate (PR). [ Time Frame: Screening up to Day 168 ]
  • Mean change from baseline and placebo in body temperature. [ Time Frame: Screening up to Day 168 ]

Secondary Outcome Measures:
  • Area under the concentration-time curve from zero to infinite time postdose (AUCinf). [ Time Frame: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168 ]
  • Time to maximum concentration (Tmax). [ Time Frame: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168 ]
  • Maximum concentration (Cmax). [ Time Frame: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168 ]
  • Area under the concentration-time curve from zero to the last quantifiable concentration (AUClast). [ Time Frame: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168 ]
  • Terminal elimination half-life (t½). [ Time Frame: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168 ]
  • Clearance (CL). [ Time Frame: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168 ]
  • Volume of distribution (Vz). [ Time Frame: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168 ]

Enrollment: 31
Study Start Date: October 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-04427429 Biological: PF-04427429
Intravenous, single dose given over 1 hour with experimental dose. Subjects can receive one of four potential doses - 300, 1000, 1500 or 2000 mg.
Placebo Comparator: Placebo
Normal saline
Other: Normal saline
Intravenous, normal saline

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Generally healthy women, of non-child bearing potential, between the ages of 18 and 65 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 or clinical laboratory tests.
  • Body Mass Index (BMI) of 17.5 to 35.0 kg/m2; and a total body weight between 50 kg (110 lbs) and 120 kg (265 lbs) inclusive.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, hepatic, psychiatric, or neurologic, disease. Subjects with asymptomatic, seasonal allergies at the time of dosing will not be excluded.
  • Women of childbearing potential.
  • History or diagnosis of ocular disease or conditions that would confound the assessment of ocular safety, such as diabetic retinopathy, uveitis, severe wet or dry AMD.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01511497


Locations
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33126
Pfizer Investigational Site
Miami, Florida, United States, 33134
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01511497     History of Changes
Other Study ID Numbers: B0141008
First Submitted: October 18, 2011
First Posted: January 18, 2012
Last Update Posted: February 21, 2013
Last Verified: February 2013

Keywords provided by Pfizer:
Phase 1
PF-04427429

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases