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NCT Number: NCT01469468

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

South Miami, Florida, 33143, United States

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

simvastatin

Drug

Day 1: Single dose of simvastatin 20 mg Day 8: single dose of simvastatin 20 mg (with PF-05175157)

PF-05175157

Drug

Days 2-9 inclusive: daily dosing of PF-05175157 200 mg

Primary outcomes

  1. Area under the plasma concentration curve of simvastatin and simvastatin acid

    Time frame: 10 days

  2. Maximum observed plasma concentration of simvastatin and simvastatin acid

    Time frame: 10 days

  3. Time at which maximum plasma concentration of simvastatin and simvastatin acid is observed

    Time frame: 10 days

  4. If the data permit, area under the plasma concentration curve of simvastatin and simvastatin acid extrapolated to infinite time

    Time frame: 10 days

  5. If the data permit, terminal elimination half-life of simvastatin and simvastatin acid

    Time frame: 10 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-05175157 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
Nov 10, 2011
Registry last updated
Nov 14, 2018

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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