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

NCT ID: NCT02080468

Last Updated: 2019-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-19
• Study Completion Date: 2014-04-24

Brief 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.

Detailed Description

This study will be a single center, randomized, open-label, 2 arm study to evaluate the effects of EE/norgestimate, a weak CYP3A4 inhibitor, on the PK of lomitapide in healthy female subjects when EE/norgestimate is administered simultaneously with lomitapide and when administration is separated by 12 hours.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Arm 1: Lomitapide & EE/Norgestimate - Taken Together

Lomitapide \& EE/Norgestimate - Taken Together 2 single oral doses of lomitapide (20 mg) (Day 1 \& Day 22) 21 single oral doses of EE/Norgestimate(Day 8 through day 28)

Group Type: EXPERIMENTAL

lomitapide

Intervention Type: DRUG

20 mg

EE/norgestimate

Intervention Type: DRUG

1x0.035-mg EE/0.25-mg norgestimate tablet

Arm 2: Lomitapide & EE/Norgestimate - Taken 12 Hours Apart

Lomitapide \& EE/Norgestimate - Taken 12 hours apart 2 single oral doses of lomitapide (20 mg) (Day 1 \& Day 22) 21 single oral doses of EE/Norgestimate(Day 9 through day 29)

Group Type: EXPERIMENTAL

lomitapide

Intervention Type: DRUG

20 mg

EE/norgestimate

Intervention Type: DRUG

1x0.035-mg EE/0.25-mg norgestimate tablet

Interventions

lomitapide

20 mg

Intervention Type: DRUG

EE/norgestimate

1x0.035-mg EE/0.25-mg norgestimate tablet

Intervention Type: DRUG

Other Intervention Names

Juxtapid; Ortho Cylclen

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Aegerion Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Sumeray, MD

Role: STUDY_CHAIR

Cheif Medical Officer

T. Alex King, MD, CPI

Role: PRINCIPAL_INVESTIGATOR

Covance

Locations

Covance Clinical Research Unit, Inc

Dallas, Texas, United States

Countries

United States

Other Identifiers

AEGR-733-029

Identifier Type: -

Identifier Source: org_study_id