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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01469468
First received: October 29, 2011
Last updated: December 27, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Simvastatin
Drug: PF-05175157
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-05175157 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:
  • Area under the plasma concentration curve of simvastatin and simvastatin acid [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • Maximum observed plasma concentration of simvastatin and simvastatin acid [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • Time at which maximum plasma concentration of simvastatin and simvastatin acid is observed [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • If the data permit, area under the plasma concentration curve of simvastatin and simvastatin acid extrapolated to infinite time [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • If the data permit, terminal elimination half-life of simvastatin and simvastatin acid [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: November 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single arm, fixed sequence dosing Drug: Simvastatin
Day 1: Single dose of simvastatin 20 mg Day 8: single dose of simvastatin 20 mg (with PF-05175157)
Drug: PF-05175157
Days 2-9 inclusive: daily dosing of PF-05175157 200 mg

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01469468

Locations
United States, Florida
Pfizer Investigational Site
South Miami, Florida, United States, 33143
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: NCT01469468     History of Changes
Other Study ID Numbers: B1731012
Study First Received: October 29, 2011
Last Updated: December 27, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014