A Study To Investigate The Safety And Toleration Of A Single Dose Of PF-04418948 In Healthy Volunteers
October 22, 2010 updated by: Pfizer
A Double-Blind (3rd Party Open), Randomized, Placebo Controlled, Dose Escalating, Parallel Group Study To Investigate The Safety, Toleration And Pharmacokinetics Of Single Doses Of PF-04418948 In Healthy Male Subjects
The purpose of this study is to investigate safety and toleration of single oral doses as well as the time course of PF-04418948 concentration in the blood following dosing by oral solution.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
56
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bruxelles, Belgium, 1070
- Pfizer Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy male subjects between the ages of 18 and 55 years.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m^2; and a total body weight >50 kg (110 lbs).
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- A positive urine drug screen.
- History of regular alcohol consumption exceeding 21 drinks/week for males.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PF-04418948 30 mg
|
solution, 30 mg, single
solution, 100 mg, single
solution, 300 mg, single
solution, 1000 mg, single
solution, 3000 mg, single
solution, 4500 mg, single
solution, 6000 mg, single
|
|
Experimental: PF-04418948 100 mg
|
solution, 30 mg, single
solution, 100 mg, single
solution, 300 mg, single
solution, 1000 mg, single
solution, 3000 mg, single
solution, 4500 mg, single
solution, 6000 mg, single
|
|
Experimental: PF-04418948 300 mg
|
solution, 30 mg, single
solution, 100 mg, single
solution, 300 mg, single
solution, 1000 mg, single
solution, 3000 mg, single
solution, 4500 mg, single
solution, 6000 mg, single
|
|
Experimental: PF-04418948 1000 mg
|
solution, 30 mg, single
solution, 100 mg, single
solution, 300 mg, single
solution, 1000 mg, single
solution, 3000 mg, single
solution, 4500 mg, single
solution, 6000 mg, single
|
|
Experimental: PF-04418948 3000 mg
|
solution, 30 mg, single
solution, 100 mg, single
solution, 300 mg, single
solution, 1000 mg, single
solution, 3000 mg, single
solution, 4500 mg, single
solution, 6000 mg, single
|
|
Experimental: PF-04418948 4500 mg
|
solution, 30 mg, single
solution, 100 mg, single
solution, 300 mg, single
solution, 1000 mg, single
solution, 3000 mg, single
solution, 4500 mg, single
solution, 6000 mg, single
|
|
Experimental: PF-04418948 6000 mg
|
solution, 30 mg, single
solution, 100 mg, single
solution, 300 mg, single
solution, 1000 mg, single
solution, 3000 mg, single
solution, 4500 mg, single
solution, 6000 mg, single
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Plasma pharmacokinetic parameters: Cmax, Tmax, AUClast, AUCtau, AUCinf, Cav, CL/F, V/F, t1/2
Time Frame: 240 hours
|
240 hours
|
|
Safety: Adverse events, vital signs measurements, telemetry, 12-lead ECGs, physical examination findings, blood safety tests, fecal occult blood (FOB), cardiac troponin measurements, urine safety tests (KIM-1 measurements and creatinine).
Time Frame: 240 hours
|
240 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pharmacodynamics: Emax (maximum observed increase in TNFα concentration from pre-dose level) TEmax (time to Emax), AUEClast, AUECt (where t will be a defined timepoint) and maximum n-fold increase in concentration from pre-dose level.
Time Frame: 48 hours
|
48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
February 1, 2010
Study Completion (Actual)
February 1, 2010
Study Registration Dates
First Submitted
October 27, 2009
First Submitted That Met QC Criteria
October 27, 2009
First Posted (Estimate)
October 28, 2009
Study Record Updates
Last Update Posted (Estimate)
October 25, 2010
Last Update Submitted That Met QC Criteria
October 22, 2010
Last Verified
October 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- B0631001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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