A Phase II, Fixed-sequenced, Open- Label, Research Study to Assess Pharmacokinetic Drug Interactions of AEGR-733 on Lipid-lowering Therapies in Healthy Volunteers

NCT00359281 Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	Aegerion Pharmaceuticals, Inc.
Phase	Phase 2
Status	COMPLETED
Enrolment	125
Start date	2006-03
Completion	2007-11

Conditions

• Healthy

Interventions

• atorvastatin
• simvastatin
• ezetimibe
• fenofibrate
• dextromethorphan
• Extended Release Niacin

Primary outcomes

• Area Under Concentration-time Curve From 0 to Last Measureable Concentration (AUC0-t) Atorvastatin Acid (Lomitapide 10 mg) — 0 to 24 hour
  Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for atorvastatin acid (Lomitapide 10 mg)
• AUC0-t Simvastatin — 0 to 24 hours
  Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for simvastatin
• AUC0-t Simvastatin Acid — 0 to 24 hours
  Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for simvastatin acid
• AUC0-t Total Ezetimibe — 0 to 24 hours
  Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for total ezetimibe
• AUC0-t Rosuvastatin (Lomitapide 10 mg) — 0 to 24 hours
  Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for rosuvastatin (Lomitapide 10 mg)
• AUC0-t Fenofibric Acid — 0 to 24 hours
  Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for fenofibric acid

Countries

United States