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

Primary Purpose

Pain, Migraine Disorders

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

PF-04427429

Normal saline

About this trial

This is an interventional treatment trial for Pain focused on measuring Phase 1, PF-04427429

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

Pfizer Investigational Site
Pfizer Investigational Site
Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PF-04427429

Placebo

Arm Description

Normal saline

Outcomes

Primary Outcome Measures

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

Incidence and severity of clinical laboratory abnormalities.

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

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

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

Anti-Drug Antibodies (ADA) responses.

Intravenous (IV) injection site reactions.

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

Mean change from baseline and placebo in body temperature.

Secondary Outcome Measures

Area under the concentration-time curve from zero to infinite time postdose (AUCinf).

Time to maximum concentration (Tmax).

Maximum concentration (Cmax).

Area under the concentration-time curve from zero to the last quantifiable concentration (AUClast).

Terminal elimination half-life (t½).

Clearance (CL).

Volume of distribution (Vz).

Full Information

NCT ID

NCT01511497

First Posted

October 18, 2011

Last Updated

February 20, 2013

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01511497

Brief Title

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

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Migraine Disorders

Keywords

Phase 1, PF-04427429

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PF-04427429

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Normal saline

Intervention Type

Biological

Intervention Name(s)

PF-04427429

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Normal saline

Intervention Description

Intravenous, normal saline

Primary Outcome Measure Information:

Title

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

Time Frame

Screening up to Day 168

Title

Incidence and severity of clinical laboratory abnormalities.

Time Frame

Screening up to Day 168

Title

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

Time Frame

Screening up to Day 168

Title

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

Time Frame

Screening up to Day 168

Title

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

Time Frame

Screening up to Day 168

Title

Anti-Drug Antibodies (ADA) responses.

Time Frame

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

Title

Intravenous (IV) injection site reactions.

Time Frame

Day 1 post dose

Title

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

Time Frame

Screening up to Day 168

Title

Mean change from baseline and placebo in body temperature.

Time Frame

Screening up to Day 168

Secondary Outcome Measure Information:

Title

Area under the concentration-time curve from zero to infinite time postdose (AUCinf).

Time Frame