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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01103739
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 12

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Drug: PF-04531083; Drug: simvastatin; Drug: PF-04531083; Drug: simvastatin	Phase 1

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• 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
• Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: May 1, 2010
• Actual Study Completion Date: May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: cohort 1	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.
Experimental: cohort 2	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.

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics of simvastatin. AUC, Cmax and half life. [days 1 and 14 of study]

2. Pharmacokinetics of simvastatin acid. AUC, Cmax and half life. [days 1 and 14 of study]

3. 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

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• young

• healthy

• male and female volunteers

Exclusion Criteria:

• Elderly

• Patients

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Bruxelles		Belgium	1070

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01103739
• Other Study ID Numbers: B1351007
• First Posted: Apr 15, 2010
• Last Update Posted: Jun 4, 2010
• Last Verified: Jun 1, 2010

• Keywords provided by , ,: pharmacokinetics; drug-drug interaction
• Additional relevant MeSH terms: Chronic Pain; Simvastatin

Study Results

No Results Posted as of Jun 4, 2010