NCT01511497

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_1 pain

Timeline
Completed

Started Oct 2011

Typical duration for phase_1 pain

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2011

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 18, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

February 21, 2013

Status Verified

February 1, 2013

Enrollment Period

1.3 years

First QC Date

October 18, 2011

Last Update Submit

February 20, 2013

Conditions

PainMigraine Disorders

Keywords

Phase 1PF-04427429

Outcome Measures

Primary Outcomes (9)

  • 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 Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

PF-04427429

EXPERIMENTAL
Biological: PF-04427429

Placebo

PLACEBO COMPARATOR

Normal saline

Other: Normal saline

Interventions

PF-04427429BIOLOGICAL

Intravenous, single dose given over 1 hour with experimental dose. Subjects can receive one of four potential doses - 300, 1000, 1500 or 2000 mg.

PF-04427429
Normal salineOTHER

Intravenous, normal saline

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pfizer Investigational Site

Miami, Florida, 33126, United States

Location

Pfizer Investigational Site

Miami, Florida, 33134, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75247, United States

Location

Related Links

MeSH Terms

Conditions

PainMigraine Disorders

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2011

First Posted

January 18, 2012

Study Start

October 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

February 21, 2013

Record last verified: 2013-02

Locations

US(3)