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Trial record 1 of 1 for:    NCT01445860
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Drug-Drug Interaction Study Of Effect Of PF-03882845 On Simvastatin Pharmacokinetics

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ClinicalTrials.gov Identifier: NCT01445860
Recruitment Status : Completed
First Posted : October 4, 2011
Last Update Posted : October 4, 2011
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE July 11, 2011
First Posted Date  ICMJE October 4, 2011
Last Update Posted Date October 4, 2011
Study Start Date  ICMJE August 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2011)
Composite (or Profile) of Pharmacokinetics [ Time Frame: 15 days ]
AUCinf, AUClast, Cmax, Tmax, t1/2 of simvastatin and simvastatin acid
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2011)
Number of patients with adverse events as a measure of safety. [ Time Frame: 15 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Drug-Drug Interaction Study Of Effect Of PF-03882845 On Simvastatin Pharmacokinetics
Official Title  ICMJE A Phase 1, Open-Label, Fixed-Sequence Study To Estimate The Effect Of Repeated Dosing Of PF-03882845 On The Pharmacokinetics Of A Single Dose Of Simvastatin In Healthy Adult Subjects
Brief Summary The purpose of this study is to estimate the effect of multiple oral doses of PF-03882845 on the pharmacokinetics of simvastatin and simvastatin acid in healthy, adult subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Human Volunteers
Intervention  ICMJE Drug: Simvastatin/PF-03882845
Single dose 20 mg simvastatin on Day 1, 30 mg PF-03882845 once daily from Days 2 to 13, the single dose 20 mg simvastatin on Day 12.
Study Arms  ICMJE Experimental: Treatment
Intervention: Drug: Simvastatin/PF-03882845
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 30, 2011)
14
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy males and/or females of non-childbearing potential between the ages of 18 (or 21 based on country-specific age of consent) and 60 years, inclusive, at Screening. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG or clinical/safety laboratory tests.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 inclusive; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

  • Use of CYP3A4 inhibitors (eg, ketoconazole, ciprofloxacin, diltiazem) or inducers (eg, pheytoin, carbamazepine) or substrate (eg, simvastatin, quinidine) within 28 days or 5 half-lives (whichever is longer) prior to Day 1.
  • Known history of hypersensitivity, allergy, severe adverse drug reaction or intolerance to simvastatin or other statins.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01445860
Other Study ID Numbers  ICMJE B0171013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP