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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01103739

Enrollment

Registered

2010-04-15

Start date

2010-03-31

Completion date

2010-05-31

Last updated

2010-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

Keywords

pharmacokinetics, drug-drug interaction

Brief summary

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.

Detailed description

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

Interventions

DRUGPF-04531083

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

DRUGsimvastatin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* young * healthy * male and female volunteers

Exclusion criteria

* Elderly * Patients

Design outcomes

Primary

Measure	Time frame
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
Pharmacokinetics of simvastatin. AUC, Cmax and half life.	days 1 and 14 of study

Secondary

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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026