At a glance
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A Phase II, Fixed-sequenced, Open- Label, Research Study to Assess Pharmacokinetic Drug Interactions of AEGR-733 on Lipid-lowering Therapies in Healthy Volunteers
In Brief
A Phase 2 clinical trial evaluating atorvastatin, simvastatin, and 4 other interventions for Healthy. Completed, enrolled 125 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Atrovastatin 20 mg and AEGR-733 10 mg or 60 mg
Simvastatin 20 mg and AEGR-733 10 mg or 60 mg
Ezetimibe 10 mg and AEGR-733 10 mg
Micronized Fenofibrate 145 mg and AEGR-733 10 mg
Dextromethorphan 30 mg and AEGR-733 10 mg
1000 mg ER niacin and AEGR-733 10 mg