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Sponsors and Collaborators: |
University of Pennsylvania Aegerion Pharmaceuticals, Inc. |
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Information provided by: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT00359281 |
This phase II, open-label research study will be conducted in 125 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.
Condition | Intervention | Phase |
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Healthy |
Drug: atorvastatin Drug: simvastatin Drug: ezetimibe Drug: fenofibrate Drug: dextromethorphan Drug: Extended Release Niacin |
Phase II |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Fixed-Sequenced, Open- Label, Research Study to Assess Pharmacokinetic Drug Interactions of AEGR-733 on Lipid-Lowering Therapies in Healthy Volunteers |
Enrollment: | 125 |
Study Start Date: | March 2006 |
Study Completion Date: | November 2007 |
Objectives:
Primary: To evaluate the effects of low and high doses of AEGR-733 on the pharmacokinetics of 6 FDA-approved medications that are likely to be used in combination with AEGR-733 as assessed by:
• Pharmacokinetic parameters: Cmax, Tmax, T1/2, and AUC (area under the curve).
Secondary: To evaluate the safety of AEGR-733 in combination with other lipid lowering agents in healthy subject as assessed by:
4.0 STUDY DESIGN AND RATIONALE
4.1 STUDY DESIGN This is a single-center, phase II, clinical trial consisting of a eight (8) day open-label phase to assess the pharmacokinetic drug interactions of AEGR-733 on 6 probe drugs in healthy volunteers, followed by a one week safety visit. 105 subjects will be enrolled into this fixed-sequenced research study. Eligible subjects based on the screening visit will come to the GCRC for an inpatient visit (25-36 hr depending on if they come in evening before study day 1 or morning of). On the morning of study day 1, subjects will be assigned to one of 6 probe drugs(A-H below) and will take one dose of this medication. Timed blood samples will be drawn just before the administration of the probe drug and during the following times after drug administration (1,2,3,4,5,6,8,10,12,18, and 24 hrs). Prior to discharge after the 24 h blood sample, subjects will take an oral dose of AEGR-733 at 10 mg or 60 mg. Subjects will be given a 5 day supply of AEGR-733 at 10 mg or 60 mg to be taken once daily in the morning for the next 5 days (through day 7). On study day 8, subjects will take a final dose of AEGR-733 at 10 mg or 60 mg (total doses= 7) simultaneously with the same probe drug they took on day 1. Timed blood samples will be drawn just before the administration of the probe drug and AEGR-733 as well as 1,2,3,4,5,6,8,10,12,18, and 24 hours after study drug administration. After the 24 hour blood sample, subjects will be discharged. 15 subjects who participate in this study will receive dextromethorphan as the probe drug, which requires urine collection for 8 hours post dose. Blood for pharmacokinetic samples will not be collected on these subjects. Subjects receiving dextromethorphan may leave after the 8 hour urine collection at visits 2 and 3 (referred to as the inpatient visits). All subjects will come back 1 week later for a final visit to check safety lab parameters including liver transaminases and total bilirubin. Subjects will be instructed to abstain from drinking any alcoholic beverages once screened until study completion. Subjects who are not willing to comply with these requests will not be enrolled.
The FDA-approved lipid-lowering therapies will include:
A) Atorvastatin, 20 mg (n=15)and AEGR-733 10 mg B) Ezetimibe, 10 mg (n=10)and AEGR-733 10 mg C) Simvastatin, 20 mg (n=15)and AEGR-733 10 mg D) Rosuvastatin, 20 mg (n=10)and AEGR-733 10 mg E) Micronized fenofibrate, 145 mg (n=10)and AEGR-733 10 mg F) Atorvastatin, 20 mg (n=15) and AEGR-733 60 mg G) Rosuvastatin, 20 mg (n=15) and AEGR-733 60 mg H) Dextromethorphan, 30 mg (n=15) and AEGR-733 60 mg I) Extended Release Niacin, 1000 mg (n=20) and AEGR-733 10 mg
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Males and non-pregnant/non-lactating female subjects between the ages of 18 and 70 who are in good overall health.
To be eligible for enrollment in this study, patients must meet all of the following criteria:
Exclusion Criteria:
United States, Pennsylvania | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Marina Cuchel, MD, PhD | University of Pennsylvania |
Responsible Party: | Aegerion Pharmaceuticals ( Matthew Parris ) |
Study ID Numbers: | 804344, Aegerion 002 PK study |
Study First Received: | July 31, 2006 |
Last Updated: | November 30, 2007 |
ClinicalTrials.gov Identifier: | NCT00359281 |
Health Authority: | United States: Food and Drug Administration |
healthy volunteers |
Excitatory Amino Acids Simvastatin Ezetimibe Healthy Procetofen Naphazoline Nicotinic Acids |
Oxymetazoline Guaifenesin Phenylephrine Dextromethorphan Phenylpropanolamine Niacin Atorvastatin |
Antimetabolites Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antilipemic Agents Physiological Effects of Drugs Enzyme Inhibitors Excitatory Amino Acid Agents |
Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Therapeutic Uses Antitussive Agents Central Nervous System Agents Excitatory Amino Acid Antagonists |