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

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Aegerion Pharmaceuticals, Inc.
• Treatments: Atorvastatin; Atorvastatin Calcium; Dextromethorphan; Ezetimibe; Fenofibrate; Niacin; Simvastatin

Criteria

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:

1. Men and women between the ages of 18 and 70

2. 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.

3. Subjects must be in good overall health

4. Subjects must be able to comprehend and willing to provide a signed IRB approved Informed Consent Form.

5. Subjects must be willing to comply with all study-related procedures.

Exclusion Criteria:

1. Known atherosclerotic cardiovascular disease, including coronary disease, cerebrovascular disease, or peripheral vascular disease

2. History of diabetes mellitus or fasting glucose > 126 mg/dL at the screening visit.

3. History of a non-skin malignancy within the previous 5 years

4. Renal insufficiency as defined by creatinine > 1.3 mg/dl

5. Any major active rheumatologic, pulmonary, or dermatologic disease or inflammatory condition

6. History of hypertension

7. Known coagulopathy and /or elevated PT/PTT >1.5 x ULN

8. Oral history of HIV positive

9. Patients who have undergone any organ transplant

10. Known active fibrotic or cirrhotic disease; ALT or AST > 1.5x ULN

11. Any major surgery within the previous 3 months

12. Individuals who currently use tobacco products or have done so in the previous 30 days

13. History of drug abuse (< 3 years)

14. Regular use of alcoholic beverages (> 7 drinks/day)

15. Subjects who do not agree to abstain from consuming alcoholic beverages during the entire study duration.

16. Body mass index (BMI) > 30 kg/m2 or < 18.5 kg/m2

17. Participation in an investigational drug study within 6 weeks prior to the screening visit

18. 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.

19. 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

20. 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)

21. History of myalgia with a statin or unknown hypersensitivity to any statin, zetia, AEGR-733, or fenofibrate.