Pharmacokinetic Drug Interactions of AEGR-733 on Lipid-lowering Agents

Completed · Phase 2

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT00359281

Run by

Aegerion Pharmaceuticals, Inc.

People needed

125

Starts

2006-03-01

Expected to finish

2007-11-01

Last updated by the study team

2018-02-23

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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