Evaluate the Effect of Ethinyl Estradiol/Norgestimate on the Pharmacokinetics of Lomitapide in Healthy Female Subjects

• Status: Completed
• Trial end date: 2014-04-24
• Target enrollment: 0
• Participant gender: Female

Summary

The primary objective of this study is to assess the effect of ethinyl estradiol (EE)/norgestimate, a weak cytochrome P450 (CYP) 3A4 inhibitor, on the pharmacokinetics (PK) of lomitapide and 2 primary metabolites, M1 and M3.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Aegerion Pharmaceuticals, Inc.
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Fluoroquinolones; Moxifloxacin; Norgestimate; Norgestimate, ethinyl estradiol drug combination; Norgestrel; Polyestradiol phosphate

Criteria

Inclusion Criteria:

1. Healthy females, between 18 and 40 years of age inclusive

2. BMI between 18.5 and 30.0 kg/m2, inclusive; total body weight of >110 lbs (50 kg);

3. in good health, determined by no clinically significant or relevant abnormalities identified by a detailed medical history and physical exam

4. no known history of hypersensitivity or previous intolerance to lomitapide or EE/norgestimate

5. creatine phosphokinase, AST, and ALT levels must be below 1.5 times the upper limit of normal

6. clinical laboratory evaluations within the reference range for the test laboratory

7. negative test for selected drugs of abuse

8. negative hepatitis panel and negative HIV antibody screens

9. are of childbearing potential(ie, not postmenopausal or surgically sterile). All subjects must have a negative serum beta pregnancy test.

10. able to comprehend and willing to sign an Informed Consent Form

Exclusion Criteria:

1. significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, GI, neurological, or psychiatric disorder

2. history of unexplained breast abnormalities or abnormal uterine bleeding

3. history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance

4. history of stomach or intestinal surgery or resection

5. history of Gilbert's Syndrome or suspicion of Gilbert's Syndrome

6. subjects who have an abnormality in the 12-lead ECG

7. use of any drugs of abuse for 6 months prior to Check-in;

8. subjects who consume more than 14 units of alcohol per week or who have a significant history of alcoholism or drug/chemical abuse within 1 year prior to Check-in

9. use of any tobacco- or nicotine-containing products within 6 months prior to Check-in;

10. participation in any other investigational study drug trial within 30 days prior to Check-in;

11. use of any prescription medications/products within 14 days prior to Check-in unless deemed acceptable by the Investigator and Sponsor

12. use of any over-the-counter, nonprescription preparations within 7 days prior to Check-in, unless deemed acceptable by the Investigator and Sponsor

13. use of alcohol-, grapefruit- (including star fruit), or caffeine-containing foods or beverages within 72 hours prior to Check-in and through Study Completion

14. use of oral (except scheduled administration of EE/norgestimate), implantable, injectable, or transdermal contraceptives

15. use of hormone replacement therapy

16. poor peripheral venous access;

17. donation of blood (500 mL) from 30 days prior to Screening through Study Completion

18. receipt of blood products within 2 months prior to Check-in;

19. any acute or chronic condition, scheduled hospitalization (inclusive of elective surgery during study) or scheduled travel prior to completion of all study procedures which, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study;

20. subjects who, in the opinion of the Investigator, should not participate in this study.