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Completed

NCT Number: NCT01103739

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

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Brussels, 1070, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • young
  • healthy
  • male and female volunteers

Exclusion criteria

  • Elderly
  • Patients

Treatment and study plan

PF-04531083

Drug

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

simvastatin

Drug

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

Primary outcomes

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

    Time frame: days 1 and 14 of study

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

    Time frame: days 1 and 14 of study

  3. 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

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

    Time frame: days 1 and 15 of the study

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 15, 2010
Registry last updated
Jun 4, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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