Back to resultsA Study To Estimate The Effect Of Repeated Dosing of PF-05175157 On The Pharmacokinetics Of A Single Dose Of Simvastatin In Healthy Adult Subjects
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Simvastatin
PF-05175157
Sponsored by
About this trial
This is an interventional basic science trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Healthy subjects with normal results in all screening examinations.
- Body Mass Index of 17.5 to 35.5 kg/m2
Exclusion Criteria:
- 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.
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single arm, fixed sequence dosing
Arm Description
Outcomes
Primary Outcome Measures
Area under the plasma concentration curve of simvastatin and simvastatin acid
Maximum observed plasma concentration of simvastatin and simvastatin acid
Time at which maximum plasma concentration of simvastatin and simvastatin acid is observed
If the data permit, area under the plasma concentration curve of simvastatin and simvastatin acid extrapolated to infinite time
If the data permit, terminal elimination half-life of simvastatin and simvastatin acid
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01469468
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single arm, fixed sequence dosing
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Intervention Description
Day 1: Single dose of simvastatin 20 mg Day 8: single dose of simvastatin 20 mg (with PF-05175157)
Intervention Type
Drug
Intervention Name(s)
PF-05175157
Intervention Description
Days 2-9 inclusive: daily dosing of PF-05175157 200 mg
Primary Outcome Measure Information:
Title
Area under the plasma concentration curve of simvastatin and simvastatin acid
Time Frame
10 days
Title
Maximum observed plasma concentration of simvastatin and simvastatin acid
Time Frame
10 days
Title
Time at which maximum plasma concentration of simvastatin and simvastatin acid is observed
Time Frame
10 days
Title
If the data permit, area under the plasma concentration curve of simvastatin and simvastatin acid extrapolated to infinite time
Time Frame
10 days
Title
If the data permit, terminal elimination half-life of simvastatin and simvastatin acid
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy subjects with normal results in all screening examinations.
Body Mass Index of 17.5 to 35.5 kg/m2
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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
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