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

NCT ID: NCT01103739

Last Updated: 2010-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

cohort 1

Group Type EXPERIMENTAL

PF-04531083

Intervention Type DRUG

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

simvastatin

Intervention Type DRUG

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

cohort 2

Group Type EXPERIMENTAL

PF-04531083

Intervention Type DRUG

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.

simvastatin

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PF-04531083

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

Intervention Type DRUG

simvastatin

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

Intervention Type 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.

Intervention Type DRUG

simvastatin

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* young
* healthy
* male and female volunteers

Exclusion Criteria

* Elderly
* Patients
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pfizer, Inc.

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

Brussels, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Related Links

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B1351007

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.