Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-04427429 in healthy women.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-04427429 | Experimental |
| |
| Placebo | Placebo Comparator | Normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04427429 | Biological | Intravenous, single dose given over 1 hour with experimental dose. Subjects can receive one of four potential doses - 300, 1000, 1500 or 2000 mg. |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Miami | Florida | 33126 | United States | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051270 | Headache Disorders, Primary |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Normal saline | Other | Intravenous, normal saline |
|
| 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 |
| Miami |
| Florida |
| 33134 |
| United States |
| Pfizer Investigational Site | Dallas | Texas | 75247 | United States |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |