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

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 Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Migraine

U.S. FDA Resources

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 ] [ 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 ]

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 ] [ 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 ]

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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01511497

Locations

United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33134
Pfizer Investigational Site
Miami, Florida, United States, 33126
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:

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01511497 History of Changes
Other Study ID Numbers:	B0141008
Study First Received:	October 18, 2011
Last Updated:	February 20, 2013
Health Authority:	United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013