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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Drug: PF-04531083; Drug: simvastatin; Drug: PF-04531083

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, 1070
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• young
• healthy
• male and female volunteers

Exclusion Criteria:

• Elderly
• Patients

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.; 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.
Experimental: cohort 2	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics of simvastatin. AUC, Cmax and half life.	days 1 and 14 of study
Pharmacokinetics of simvastatin acid. AUC, Cmax and half life.	days 1 and 14 of study
Trough concentrations of PF-04531083 2, 4, 7, 11 and 14 days post commencement of dosing	days 2, 4, 7, 11 and 14 of the study

Secondary Outcome Measures

Outcome Measure	Time Frame
safety and tolerability of PF-04531083 and simvastatin. Vital signs, laboratory tests and adverse events	days 1 and 15 of the study

Collaborators and Investigators

• Sponsor: Pfizer

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: February 26, 2010
• First Submitted That Met QC Criteria: April 13, 2010
• First Posted (Estimate): April 15, 2010

Study Record Updates

• Last Update Posted (Estimate): June 4, 2010
• Last Update Submitted That Met QC Criteria: June 3, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: pharmacokinetics; drug-drug interaction
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Simvastatin
• Other Study ID Numbers: B1351007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No