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

Phase 1

Completed

• Conditions: Chronic Pain
• Interventions: Drug: PF-04531083; Drug: simvastatin

• Registration Number: NCT01103739
• Lead Sponsor: Pfizer

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

Study Timeline

• Study First Submitted: 2010-02-26
• Study Start: 2010-03
• Study First Submitted QC: 2010-04-13
• Study First Posted: 2010-04-15
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-03
• Last Update Posted: 2010-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• young
• healthy
• male and female volunteers

Exclusion Criteria

• Elderly
• Patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cohort 1	PF-04531083	-
cohort 1	simvastatin	-
cohort 2	simvastatin	-
cohort 2	PF-04531083	-

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Bruxelles, Belgium