Group Study To Investigate The Safety, Toleration And Pharmacokinetics Of Multiple Oral Doses Of PF-04531083 In Healthy Subjects
A Double Blind, 3rd Party Open, Placebo Controlled, Dose Escalating, Parallel Group Study To Investigate The Safety, Toleration And Pharmacokinetics Of Multiple Oral Doses Of PF-04531083 In Healthy Subjects
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of this study is to determine the safety and toleration of single and multiple doses of PF-04531083. (To investigate the plasma and urinary pharmacokinetics of PF-04531083 and its metabolites, following single and multiple dose administration in healthy male and/or female subjects; and to determine whether PF-04531083 raises levels of enzymes involved in metabolism of other drugs following multiple dosing).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy-volunteers
Started Nov 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 11, 2009
CompletedFirst Posted
Study publicly available on registry
November 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedApril 16, 2010
April 1, 2010
3 months
November 11, 2009
April 15, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Pharmacokinetics of PF-04531083 Cmax, Tmax, AUCtau, AUCinf, T1/2, accumulation index
days 1-15
Safety of subjects following multiple dosing of PF-04531083 (adverse events, vital signs measurements, telemetry, 12-lead ECGs, physical examination findings, blood and urine safety tests)
days 1-15
Secondary Outcomes (1)
pharmacokinetics of alternative formulations
days 1-15
Study Arms (4)
Cohort 1
EXPERIMENTALCohort 2
EXPERIMENTALCohort 3
EXPERIMENTALCohort 4
EXPERIMENTALInterventions
Subjects will receive multiple oral doses of less than or equal to 100mg PF-04531083 or placebo for 14 days.
Eligibility Criteria
You may qualify if:
- Healthy male and/or female subjects btween the ages of 18-55 years
- Body Mass Index (BMI) of 15.5 to 30.5 and a total body weight greater than 50kg (110 lbs).
You may not qualify if:
- Evidence or history of clinically signifcant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
- A positive urine drug screen.
- History of regular alcohol consumption exceeding 21 drinks/week within 6 months of screening
- Use of tobacco or nicotine containing products in excess of the equivalent of 5 cigarettes per day.
- Pregnant or nursing females; females of childbearing potentioal who are unwilling or unable to use an acceptable method on contraception.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
Brussels, 1070, Belgium
Related Links
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
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 11, 2009
First Posted
November 13, 2009
Study Start
November 1, 2009
Primary Completion
February 1, 2010
Study Completion
April 1, 2010
Last Updated
April 16, 2010
Record last verified: 2010-04