Status:
COMPLETED
Pharmacokinetic Drug Interactions of AEGR-733 on Lipid-lowering Agents
Lead Sponsor:
Aegerion Pharmaceuticals, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 d...
Detailed Description
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 assesse...
Eligibility Criteria
Inclusion
- 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:
- Men and women between the ages of 18 and 70
- Women of child-bearing potential, that is, women not surgically sterilized and between menarche and 1 year post menopause, must test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a reliable method of non-medication birth control (for example, a reliable barrier method of birth control \[diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices\]; partner with vasectomy; or abstinence) during the study and for one month following the last dose of study drug.
- Subjects must be in good overall health
- Subjects must be able to comprehend and willing to provide a signed IRB approved Informed Consent Form.
- Subjects must be willing to comply with all study-related procedures.
Exclusion
- Known atherosclerotic cardiovascular disease, including coronary disease, cerebrovascular disease, or peripheral vascular disease
- History of diabetes mellitus or fasting glucose \> 126 mg/dL at the screening visit.
- History of a non-skin malignancy within the previous 5 years
- Renal insufficiency as defined by creatinine \> 1.3 mg/dl
- Any major active rheumatologic, pulmonary, or dermatologic disease or inflammatory condition
- History of hypertension
- Known coagulopathy and /or elevated PT/PTT \>1.5 x ULN
- Oral history of HIV positive
- Patients who have undergone any organ transplant
- Known active fibrotic or cirrhotic disease; ALT or AST \> 1.5x ULN
- Any major surgery within the previous 3 months
- Individuals who currently use tobacco products or have done so in the previous 30 days
- History of drug abuse (\< 3 years)
- Regular use of alcoholic beverages (\> 7 drinks/day)
- Subjects who do not agree to abstain from consuming alcoholic beverages during the entire study duration.
- Body mass index (BMI) \> 30 kg/m2 or \< 18.5 kg/m2
- Participation in an investigational drug study within 6 weeks prior to the screening visit
- Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study will be excluded.
- Currently taking any prescription, including oral contraceptives, or OTC medication regularly that cannot be stopped for at least 30 days prior to enrollment until completion of the study
- Regular consumers of grapefruit juice, or have taken any medications known to be metabolized by CYP 3A4 within 4 weeks prior to the screening visit (ie. SSRIs, anti-fungals, anti-biotics, etc)
- History of myalgia with a statin or unknown hypersensitivity to any statin, zetia, AEGR-733, or fenofibrate.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT00359281
Start Date
March 1 2006
End Date
November 1 2007
Last Update
February 23 2018
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104