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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

NCT01103739 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2010-06-04

No results posted yet for this study

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.

Conditions

Interventions

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.

DRUG

simvastatin

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • Belgium

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01103739 on ClinicalTrials.gov