Pain, Migraine Disorders
Conditions
Keywords
Phase 1, PF-04427429
Brief summary
The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-04427429 in healthy women.
Interventions
BIOLOGICALPF-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.
OTHERNormal saline
Intravenous, normal saline
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Screening up to Day 168 |
| Incidence and severity of clinical laboratory abnormalities. | Screening up to Day 168 |
| Mean change from baseline and placebo in blood pressure (BP). | Screening up to Day 168 |
| Mean change from baseline in 12-lead electrocardiogram (ECG) parameters compared to baseline and placebo. | Screening up to Day 168 |
| Categorical summary of QTcF compared to baseline between dose groups and placebo. | Screening up to Day 168 |
| Anti-Drug Antibodies (ADA) responses. | From Day 0 up to Day 168 and until levels return to baseline. |
| Intravenous (IV) injection site reactions. | Day 1 post dose |
| Mean change from baseline and placebo in pulse rate (PR). | Screening up to Day 168 |
| Mean change from baseline and placebo in body temperature. | Screening up to Day 168 |
Secondary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve from zero to infinite time postdose (AUCinf). | Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168 |
| Time to maximum concentration (Tmax). | Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168 |
| Maximum concentration (Cmax). | 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). | Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168 |
| Terminal elimination half-life (t½). | Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168 |
| Clearance (CL). | Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168 |
| Volume of distribution (Vz). | Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168 |
Countries
United States
Outcome results
None listed