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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01511497
• Other study ID #: B0141008
• Status: Completed
• Phase: Phase 1
• First received: October 18, 2011
• Last updated: February 20, 2013
• Start date: October 2011
• Est. completion date: January 2013

Study information

• Verified date: February 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine Disorders
• Pain

Intervention

Biological:
• PF-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.

Other:
• Normal saline
Intravenous, normal saline

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)		Screening up to Day 168	Yes
Primary	Incidence and severity of clinical laboratory abnormalities.		Screening up to Day 168	Yes
Primary	Mean change from baseline and placebo in blood pressure (BP).		Screening up to Day 168	Yes
Primary	Mean change from baseline in 12-lead electrocardiogram (ECG) parameters compared to baseline and placebo.		Screening up to Day 168	Yes
Primary	Categorical summary of QTcF compared to baseline between dose groups and placebo.		Screening up to Day 168	Yes
Primary	Anti-Drug Antibodies (ADA) responses.		From Day 0 up to Day 168 and until levels return to baseline.	Yes
Primary	Intravenous (IV) injection site reactions.		Day 1 post dose	Yes
Primary	Mean change from baseline and placebo in pulse rate (PR).		Screening up to Day 168	Yes
Primary	Mean change from baseline and placebo in body temperature.		Screening up to Day 168	Yes
Secondary	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	Yes
Secondary	Time to maximum concentration (Tmax).		Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168	Yes
Secondary	Maximum concentration (Cmax).		Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168	Yes
Secondary	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	Yes
Secondary	Terminal elimination half-life (t½).		Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168	Yes
Secondary	Clearance (CL).		Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168	Yes
Secondary	Volume of distribution (Vz).		Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168	Yes

External Links

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