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drugset / Trial / NCT00359281

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

NCT00359281 ↗

Phase 2 Completed 125 enrolled Aegerion Pharmaceuticals, Inc.
Non-randomizedParallel-groupOpen-labelDiagnostic

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.

Timeline

Start
2006-03
Primary completion
2007-11
Completion
2007-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Atorvastatin Small molecule 20 mg Oral
Subject Dextromethorphan Unknown 30 mg Oral
Subject Ezetimibe Unknown 10 mg Oral
Subject Fenofibrate Small molecule 145 mg Oral
Subject Niacin Small molecule 1000 mg Oral
Subject Simvastatin Small molecule 20 mg Oral
Subject lomitapide Small molecule 10 mg Oral
Subject lomitapide Small molecule 60 mg Oral

Indications

No indication recorded.