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Completed

NCT Number: NCT01445860

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

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.

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Key information

Conditions

Human Volunteers

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Singapore, 188770

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Simvastatin/PF-03882845

Drug

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.

Primary outcomes

  1. Composite (or Profile) of Pharmacokinetics

    Time frame: 15 days

    AUCinf, AUClast, Cmax, Tmax, t1/2 of simvastatin and simvastatin acid

Secondary outcomes

  1. Number of patients with adverse events as a measure of safety.

    Time frame: 15 days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 4, 2011
Registry last updated
Oct 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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