Clinical trial NCT01511497: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study Of PF-04427429 In Healthy Women Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Migraine Disorders
Keywords: Phase 1
PF-04427429
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-01-18
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Screening up to Day 168
measure: Incidence and severity of clinical laboratory abnormalities.
timeFrame: Screening up to Day 168
measure: Mean change from baseline and placebo in blood pressure (BP).
timeFrame: Screening up to Day 168
measure: Mean change from baseline in 12-lead electrocardiogram (ECG) parameters compared to baseline and placebo.
timeFrame: Screening up to Day 168
measure: Categorical summary of QTcF compared to baseline between dose groups and placebo.
timeFrame: Screening up to Day 168
measure: Anti-Drug Antibodies (ADA) responses.
timeFrame: From Day 0 up to Day 168 and until levels return to baseline.
measure: Intravenous (IV) injection site reactions.
timeFrame: Day 1 post dose
measure: Mean change from baseline and placebo in pulse rate (PR).
timeFrame: Screening up to Day 168
measure: Mean change from baseline and placebo in body temperature.
timeFrame: Screening up to Day 168
Secondary outcomes:
measure: Area under the concentration-time curve from zero to infinite time postdose (AUCinf).
timeFrame: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168
measure: Time to maximum concentration (Tmax).
timeFrame: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168
measure: Maximum concentration (Cmax).
timeFrame: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168
measure: Area under the concentration-time curve from zero to the last quantifiable concentration (AUClast).
timeFrame: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168
measure: Terminal elimination half-life (t½).
timeFrame: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168
measure: Clearance (CL).
timeFrame: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168
measure: Volume of distribution (Vz).
timeFrame: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168
Other outcomes:
Locations:
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: