To Explore The Potential For PF-04531083 To Effect The Blood Concentrations Of Simvastatin And Its Main Acid Metabolite Following Co-Administration Of Both Medications

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01103739
First received: February 26, 2010
Last updated: June 3, 2010
Last verified: June 2010
  Purpose

The purpose of this study is to quantify the effect of multiple doses of PF-04531083 on the pharmacokinetics (PK) of co-administered single dose simvastatin.


Condition Intervention Phase
Chronic Pain
Drug: PF-04531083
Drug: simvastatin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Phase 1, Open Label, Fixed Sequence Study To Investigate The Effect Of Multiple Doses Of PF-04531083 On Simvastatin And Simvastatin Acid Pharmacokinetics Following Single Dose Of Simvastatin in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Pharmacokinetics of simvastatin. AUC, Cmax and half life. [ Time Frame: days 1 and 14 of study ] [ Designated as safety issue: No ]
  • Pharmacokinetics of simvastatin acid. AUC, Cmax and half life. [ Time Frame: days 1 and 14 of study ] [ Designated as safety issue: No ]
  • Trough concentrations of PF-04531083 2, 4, 7, 11 and 14 days post commencement of dosing [ Time Frame: days 2, 4, 7, 11 and 14 of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • safety and tolerability of PF-04531083 and simvastatin. Vital signs, laboratory tests and adverse events [ Time Frame: days 1 and 15 of the study ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: March 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cohort 1 Drug: PF-04531083
PF-04531083: 100mg to be dosed twice daily as a suspension from Day 2 through Day 14 of the study.
Drug: simvastatin
Simvastatin: a single 20mg tablet to be given on Days 1 and 14 of the study.
Experimental: cohort 2 Drug: PF-04531083
PF-04531083: a dose to be selected depending on results from Cohort 1 to be dosed twice daily as a suspension from Day 2 through Day 14 of the study.
Drug: simvastatin
Simvastatin: a single 20mg tablet to be given on Days 1 and 14 of the study.

Detailed Description:

observational- quantify any effects of PF_04531083 on the PK of Simvastatin

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • young
  • healthy
  • male and female volunteers

Exclusion Criteria:

  • Elderly
  • Patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01103739

Locations
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1070
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01103739     History of Changes
Other Study ID Numbers: B1351007
Study First Received: February 26, 2010
Last Updated: June 3, 2010
Health Authority: Belgium: Belgian Health Authority

Keywords provided by Pfizer:
pharmacokinetics
drug-drug interaction

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 23, 2014