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Pharmacokinetic Drug Interactions of AEGR-733 on Lipid-lowering Agents
NCT00359281 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG dextromethorphan
- DRUG atorvastatin
- DRUG fenofibrate
- DRUG simvastatin
- DRUG ezetimibe
Study Locations (1)
Pennsylvania
- University of Pennsylvania — Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2006-03 |
| Est. Completion | 2007-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00359281
The ClinicalTrials.gov registry entry for NCT00359281 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Aegerion Pharmaceuticals, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 5 interventions — of which dextromethorphan is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00359281 reports 1 study location spanning 1 distinct geographic area — top geographies include Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00359281 about?
NCT00359281 is a clinical study titled "Pharmacokinetic Drug Interactions of AEGR-733 on Lipid-lowering Agents". 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 subjec...
What is the current status of trial NCT00359281?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 125 participants. The study started on 2006-03. Estimated completion is 2007-11.
What conditions does trial NCT00359281 study?
This clinical trial studies the following conditions: Healthy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00359281?
The interventions under investigation include: dextromethorphan (DRUG), atorvastatin (DRUG), fenofibrate (DRUG), simvastatin (DRUG), ezetimibe (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00359281?
This trial is sponsored by Aegerion Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00359281 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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