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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01511497
First received: October 18, 2011
Last updated: February 20, 2013
Last verified: February 2013

October 18, 2011
February 20, 2013
October 2011
January 2013   (final data collection date for primary outcome measure)
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Screening up to Day 168 ] [ Designated as safety issue: Yes ]
  • Incidence and severity of clinical laboratory abnormalities. [ Time Frame: Screening up to Day 168 ] [ Designated as safety issue: Yes ]
  • Mean change from baseline and placebo in blood pressure (BP). [ Time Frame: Screening up to Day 168 ] [ Designated as safety issue: Yes ]
  • Mean change from baseline in 12-lead electrocardiogram (ECG) parameters compared to baseline and placebo. [ Time Frame: Screening up to Day 168 ] [ Designated as safety issue: Yes ]
  • Categorical summary of QTcF compared to baseline between dose groups and placebo. [ Time Frame: Screening up to Day 168 ] [ Designated as safety issue: Yes ]
  • Anti-Drug Antibodies (ADA) responses. [ Time Frame: From Day 0 up to Day 168 and until levels return to baseline. ] [ Designated as safety issue: Yes ]
  • Intravenous (IV) injection site reactions. [ Time Frame: Day 1 post dose ] [ Designated as safety issue: Yes ]
  • Mean change from baseline and placebo in pulse rate (PR). [ Time Frame: Screening up to Day 168 ] [ Designated as safety issue: Yes ]
  • Mean change from baseline and placebo in body temperature. [ Time Frame: Screening up to Day 168 ] [ Designated as safety issue: Yes ]
  • Incidence and severity of adverse events. [ Time Frame: Screening through Day 168 ] [ Designated as safety issue: Yes ]
  • Incidence and severity of clinical laboratory abnormalities. [ Time Frame: Screening through Day 168 ] [ Designated as safety issue: Yes ]
  • Mean change from baseline and placebo in blood pressure (BP). [ Time Frame: Screening through Day 168 ] [ Designated as safety issue: Yes ]
  • Mean change from baseline in 12-lead electrocardiogram (ECG) parameters compared to baseline and placebo. [ Time Frame: Screening through Day 168 ] [ Designated as safety issue: Yes ]
  • Categorical summary of QTcF compared to baseline between dose groups and placebo. [ Time Frame: Screening through Day 168 ] [ Designated as safety issue: Yes ]
  • Anti-Drug Antibodies (ADA) responses. [ Time Frame: From Day 0 through Day 168 and until levels return to baseline. ] [ Designated as safety issue: Yes ]
  • Intravenous (IV) injection site reactions. [ Time Frame: Day 1 post dose ] [ Designated as safety issue: Yes ]
  • Mean change from baseline and placebo in pulse rate (PR). [ Time Frame: Screening through Day 168 ] [ Designated as safety issue: Yes ]
  • Mean change from baseline and placebo in body temperature. [ Time Frame: Screening through Day 168 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01511497 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • Time to maximum concentration (Tmax). [ Time Frame: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168 ] [ Designated as safety issue: Yes ]
  • Maximum concentration (Cmax). [ Time Frame: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Terminal elimination half-life (t½). [ Time Frame: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168 ] [ Designated as safety issue: Yes ]
  • Clearance (CL). [ Time Frame: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168 ] [ Designated as safety issue: Yes ]
  • Volume of distribution (Vz). [ Time Frame: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study Of PF-04427429 In Healthy Women Volunteers
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

The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-04427429 in healthy women.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Pain
  • Migraine Disorders
  • 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
  • Experimental: PF-04427429
    Intervention: Biological: PF-04427429
  • Placebo Comparator: Placebo
    Normal saline
    Intervention: Other: Normal saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
January 2013
January 2013   (final data collection date for primary outcome measure)

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.
Female
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01511497
B0141008
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2013

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