A Study To Investigate The Safety And Toleration Of A Single Dose Of PF-04418948 In Healthy Volunteers
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
1 other identifier
interventional
56
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Sep 2009
Typical duration for phase_1 healthy
1 active site
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
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 27, 2009
CompletedFirst Posted
Study publicly available on registry
October 28, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedOctober 25, 2010
October 1, 2010
5 months
October 27, 2009
October 22, 2010
Conditions
Outcome Measures
Primary Outcomes (2)
Plasma pharmacokinetic parameters: Cmax, Tmax, AUClast, AUCtau, AUCinf, Cav, CL/F, V/F, t1/2
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).
240 hours
Secondary Outcomes (1)
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.
48 hours
Study Arms (7)
PF-04418948 30 mg
EXPERIMENTALPF-04418948 100 mg
EXPERIMENTALPF-04418948 300 mg
EXPERIMENTALPF-04418948 1000 mg
EXPERIMENTALPF-04418948 3000 mg
EXPERIMENTALPF-04418948 4500 mg
EXPERIMENTALPF-04418948 6000 mg
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
Brussels, 1070, Belgium
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 27, 2009
First Posted
October 28, 2009
Study Start
September 1, 2009
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
October 25, 2010
Record last verified: 2010-10