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

Pfizer24 enrolled

Overview

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.

observational- quantify any effects of PF\_04531083 on the PK of Simvastatin

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Chronic Pain

Interventions

PF-04531083DRUG

PF-04531083: 100mg to be dosed twice daily as a suspension from Day 2 through Day 14 of the study.

simvastatinDRUG

Simvastatin: a single 20mg tablet to be given on Days 1 and 14 of the study.

PF-04531083DRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * young * healthy * male and female volunteers Exclusion Criteria: * Elderly * Patients

Locations (1)

Pfizer Investigational Site

Brussels, Belgium

Outcomes

Primary Outcomes

Pharmacokinetics of simvastatin. AUC, Cmax and half life.

Time frame: days 1 and 14 of study

Pharmacokinetics of simvastatin acid. AUC, Cmax and half life.

Time frame: days 1 and 14 of study

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

Secondary Outcomes

safety and tolerability of PF-04531083 and simvastatin. Vital signs, laboratory tests and adverse events

Time frame: days 1 and 15 of the study

Data from ClinicalTrials.gov

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