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
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: 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:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
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 28, 2014