Drug-Drug Interaction Study Of Effect Of PF-03882845 On Simvastatin Pharmacokinetics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01445860
First received: July 11, 2011
Last updated: September 30, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Human Volunteers
Drug: Simvastatin/PF-03882845
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Composite (or Profile) of Pharmacokinetics [ Time Frame: 15 days ] [ Designated as safety issue: No ]
    AUCinf, AUClast, Cmax, Tmax, t1/2 of simvastatin and simvastatin acid


Secondary Outcome Measures:
  • Number of patients with adverse events as a measure of safety. [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]

Enrollment: 14
Study Start Date: August 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01445860

Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01445860     History of Changes
Other Study ID Numbers: B0171013
Study First Received: July 11, 2011
Last Updated: September 30, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
DDI
pharmacokinetics

Additional relevant MeSH terms:
Simvastatin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 22, 2014