A Study To Estimate The Effect Of Repeated Dosing of PF-05175157 On The Pharmacokinetics Of A Single Dose Of Simvastatin In Healthy Adult Subjects
A Phase 1, Open-Label, Fixed-Sequence Study To Estimate The Effect Of Repeated Dosing Of PF-05175157 On The Pharmacokinetics Of A Single Dose Of Simvastatin In Healthy Adult Subjects
1 other identifier
interventional
14
1 country
1
Brief Summary
The study is designed to investigate the effect of repeated dosing of PF-05175157 on the pharmacokinetics of a single dose of Simvastatin in healthy adult subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 type-2-diabetes-mellitus
Started Nov 2011
Shorter than P25 for phase_1 type-2-diabetes-mellitus
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
October 29, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedFirst Posted
Study publicly available on registry
November 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedNovember 14, 2018
November 1, 2018
1 month
October 29, 2011
November 12, 2018
Conditions
Outcome Measures
Primary Outcomes (5)
Area under the plasma concentration curve of simvastatin and simvastatin acid
10 days
Maximum observed plasma concentration of simvastatin and simvastatin acid
10 days
Time at which maximum plasma concentration of simvastatin and simvastatin acid is observed
10 days
If the data permit, area under the plasma concentration curve of simvastatin and simvastatin acid extrapolated to infinite time
10 days
If the data permit, terminal elimination half-life of simvastatin and simvastatin acid
10 days
Study Arms (1)
Single arm, fixed sequence dosing
EXPERIMENTALInterventions
Day 1: Single dose of simvastatin 20 mg Day 8: single dose of simvastatin 20 mg (with PF-05175157)
Days 2-9 inclusive: daily dosing of PF-05175157 200 mg
Eligibility Criteria
You may qualify if:
- Healthy subjects with normal results in all screening examinations.
- Body Mass Index of 17.5 to 35.5 kg/m2
You may not qualify if:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, ocular, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Known history of intolerance to simvastatin or other statins.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
South Miami, Florida, 33143, United States
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
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2011
First Posted
November 10, 2011
Study Start
November 1, 2011
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
November 14, 2018
Record last verified: 2018-11