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Completed

NCT Number: NCT01511497

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

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

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Key information

Conditions

Pain Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Miami, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Normal Saline

Other

Intravenous, normal saline

Primary outcomes

  1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Screening up to Day 168

  2. Incidence and severity of clinical laboratory abnormalities.

    Time frame: Screening up to Day 168

  3. Mean change from baseline and placebo in blood pressure (BP).

    Time frame: Screening up to Day 168

  4. Mean change from baseline in 12-lead electrocardiogram (ECG) parameters compared to baseline and placebo.

    Time frame: Screening up to Day 168

  5. Categorical summary of QTcF compared to baseline between dose groups and placebo.

    Time frame: Screening up to Day 168

  6. Anti-Drug Antibodies (ADA) responses.

    Time frame: From Day 0 up to Day 168 and until levels return to baseline.

  7. Intravenous (IV) injection site reactions.

    Time frame: Day 1 post dose

  8. Mean change from baseline and placebo in pulse rate (PR).

    Time frame: Screening up to Day 168

  9. Mean change from baseline and placebo in body temperature.

    Time frame: Screening up to Day 168

Secondary outcomes

  1. 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

  2. Time to maximum concentration (Tmax).

    Time frame: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168

  3. Maximum concentration (Cmax).

    Time frame: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168

  4. 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

  5. Terminal elimination half-life (t½).

    Time frame: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168

  6. Clearance (CL).

    Time frame: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168

  7. Volume of distribution (Vz).

    Time frame: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 18, 2012
Registry last updated
Feb 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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