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NCT00359281 · ClinicalTrials.gov registry record · Phase 2
Pharmacokinetic Drug Interactions of AEGR-733 on Lipid-lowering Agents
A Phase 2 study of Healthy, sponsored by Aegerion Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 125
- Enrollment target
- 1
- Study location
NCT00359281: Completed Phase 2 study of Healthy, sponsored by Aegerion Pharmaceuticals.
NCT00359281 is a Phase 2 study of Healthy that has completed, run by Aegerion Pharmaceuticals. The registered enrollment target is 125 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00359281, a Phase 2 study of Healthy, has completed, sponsored by Aegerion Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 125 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for atorvastatin acid (Lomitapide 10 mg)
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 |
What the finished NCT00359281 record still lists
NCT00359281 is an interventional study that assigns participants to a tested intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (81% lower).
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.
NCT00359281 reports a single indexed study location in Pennsylvania.
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.
What interventions are being tested in trial NCT00359281?
The interventions under investigation include: dextromethorphan (DRUG), atorvastatin (DRUG), fenofibrate (DRUG), simvastatin (DRUG), ezetimibe (DRUG).
Who is sponsoring clinical trial NCT00359281?
This trial is sponsored by Aegerion Pharmaceuticals, which has 11 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00359281's enrollment target sits among peer trials
125 176th of 1090 higher than 914 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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