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NCT01103739 Clinical Trial

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

Chronic Pain Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01103739
Other study ID # B1351007
Secondary ID
Status Completed
Phase Phase 1
First received February 26, 2010
Last updated June 3, 2010
Start date March 2010
Est. completion date May 2010

Study information
Verified date June 2010
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Belgium: Belgian Health Authority
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date May 2010
Est. primary completion date May 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- young

- healthy

- male and female volunteers

Exclusion Criteria:

- Elderly

- Patients

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Drug:
• PF-04531083
PF-04531083: 100mg to be dosed twice daily as a suspension from Day 2 through Day 14 of the study.
• simvastatin
Simvastatin: a single 20mg tablet to be given on Days 1 and 14 of the study.
• 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.
• simvastatin
Simvastatin: a single 20mg tablet to be given on Days 1 and 14 of the study.

Locations
Country Name City State
Belgium Pfizer Investigational Site Bruxelles

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetics of simvastatin. AUC, Cmax and half life. days 1 and 14 of study No
Primary Pharmacokinetics of simvastatin acid. AUC, Cmax and half life. days 1 and 14 of study No
Primary 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 No
Secondary safety and tolerability of PF-04531083 and simvastatin. Vital signs, laboratory tests and adverse events days 1 and 15 of the study Yes
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