Drug-Drug Interaction Study Of Effect Of PF-03882845 On Simvastatin Pharmacokinetics
This study has been completed.
Information provided by (Responsible Party):
First received: July 11, 2011
Last updated: September 30, 2011
Last verified: September 2011
The purpose of this study is to estimate the effect of multiple oral doses of PF-03882845 on the pharmacokinetics of simvastatin and simvastatin acid in healthy, adult subjects.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||A Phase 1, Open-Label, Fixed-Sequence Study To Estimate The Effect Of Repeated Dosing Of PF-03882845 On The Pharmacokinetics Of A Single Dose Of Simvastatin In Healthy Adult Subjects|
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Composite (or Profile) of Pharmacokinetics [ Time Frame: 15 days ] [ Designated as safety issue: No ]AUCinf, AUClast, Cmax, Tmax, t1/2 of simvastatin and simvastatin acid
Secondary Outcome Measures:
- Number of patients with adverse events as a measure of safety. [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2011|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Single dose 20 mg simvastatin on Day 1, 30 mg PF-03882845 once daily from Days 2 to 13, the single dose 20 mg simvastatin on Day 12.
Contacts and Locations