To Explore The Potential For PF-04531083 To Effect The Blood Concentrations Of Simvastatin And Its Main Acid Metabolite Following Co-Administration Of Both Medications
A Phase 1, Open Label, Fixed Sequence Study To Investigate The Effect Of Multiple Doses Of PF-04531083 On Simvastatin And Simvastatin Acid Pharmacokinetics Following Single Dose Of Simvastatin in Healthy Volunteers
1 other identifier
interventional
24
1 country
1
Brief Summary
The purpose of this study is to quantify the effect of multiple doses of PF-04531083 on the pharmacokinetics (PK) of co-administered single dose simvastatin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 chronic-pain
Started Mar 2010
Shorter than P25 for phase_1 chronic-pain
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
First Submitted
Initial submission to the registry
February 26, 2010
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedFirst Posted
Study publicly available on registry
April 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedJune 4, 2010
June 1, 2010
2 months
February 26, 2010
June 3, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Pharmacokinetics of simvastatin. AUC, Cmax and half life.
days 1 and 14 of study
Pharmacokinetics of simvastatin acid. AUC, Cmax and half life.
days 1 and 14 of study
Trough concentrations of PF-04531083 2, 4, 7, 11 and 14 days post commencement of dosing
days 2, 4, 7, 11 and 14 of the study
Secondary Outcomes (1)
safety and tolerability of PF-04531083 and simvastatin. Vital signs, laboratory tests and adverse events
days 1 and 15 of the study
Study Arms (2)
cohort 1
EXPERIMENTALcohort 2
EXPERIMENTALInterventions
PF-04531083: 100mg to be dosed twice daily as a suspension from Day 2 through Day 14 of the study.
Eligibility Criteria
You may qualify if:
- young
- healthy
- male and female volunteers
You may not qualify if:
- Elderly
- Patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
Brussels, 1070, Belgium
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 26, 2010
First Posted
April 15, 2010
Study Start
March 1, 2010
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
June 4, 2010
Record last verified: 2010-06