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Trial record 1 of 1 for:    NCT01511497
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Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study Of PF-04427429 In Healthy Women Volunteers

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ClinicalTrials.gov Identifier: NCT01511497
Recruitment Status : Completed
First Posted : January 18, 2012
Last Update Posted : February 21, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE October 18, 2011
First Posted Date  ICMJE January 18, 2012
Last Update Posted Date February 21, 2013
Study Start Date  ICMJE October 2011
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2012)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 12, 2012)
  • Incidence and severity of adverse events. [ Time Frame: Screening through Day 168 ]
  • Incidence and severity of clinical laboratory abnormalities. [ Time Frame: Screening through Day 168 ]
  • Mean change from baseline and placebo in blood pressure (BP). [ Time Frame: Screening through Day 168 ]
  • Mean change from baseline in 12-lead electrocardiogram (ECG) parameters compared to baseline and placebo. [ Time Frame: Screening through Day 168 ]
  • Categorical summary of QTcF compared to baseline between dose groups and placebo. [ Time Frame: Screening through Day 168 ]
  • Anti-Drug Antibodies (ADA) responses. [ Time Frame: From Day 0 through 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 through Day 168 ]
  • Mean change from baseline and placebo in body temperature. [ Time Frame: Screening through Day 168 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study Of PF-04427429 In Healthy Women Volunteers
Official Title  ICMJE 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
Brief Summary The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-04427429 in healthy women.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Pain
  • Migraine Disorders
Intervention  ICMJE
  • 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.
  • Other: Normal saline
    Intravenous, normal saline
Study Arms  ICMJE
  • Experimental: PF-04427429
    Intervention: Biological: PF-04427429
  • Placebo Comparator: Placebo
    Normal saline
    Intervention: Other: Normal saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 20, 2013)
31
Original Estimated Enrollment  ICMJE
 (submitted: January 12, 2012)
32
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01511497
Other Study ID Numbers  ICMJE B0141008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP