Overview

Pharmacokinetic Drug Interactions of AEGR-733 on Lipid-lowering Agents

Status:
Completed
Trial end date:
2007-11-01
Target enrollment:
Participant gender:
Summary
This phase II, open-label research study was conducted in 129 healthy volunteers. Each subject will be given one initial oral dose of one of 7 FDA-approved medications (probe drugs), followed by a 7 day period where subjects receive the study medication AEGR-733 at 10 or 60 mg. On study day 8 subjects will receive the second oral dose of the same probe drug that was given on day 1 and a last dose of AEGR-733 (total of 7 doses).Subjects will return in 1 week for a final safety visit. Each FDA- approved probe drug will be given to ten (10) or fifteen (15) subjects. Safety, pharmacokinetic and pharmacodynamic assessments will be performed.
Phase:
Phase 2
Details
Lead Sponsor:
Aegerion Pharmaceuticals, Inc.
Treatments:
Atorvastatin
Atorvastatin Calcium
Dextromethorphan
Ezetimibe
Fenofibrate
Niacin
Simvastatin