A Phase 1, Open-Label, Randomized, 2-Arm Study to Evaluate the Effect of Ethinyl Estradiol/Norgestimate (Ortho Cyclen®), a Weak CYP3A4 Inhibitor, on the Pharmacokinetics of Lomitapide in Healthy Female Subjects

Aegerion Pharmaceuticals, Inc.1 个研究点分布在 1 个国家目标入组 32 人开始时间: 2014年2月19日最近更新: 2019年3月11日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Aegerion Pharmaceuticals, Inc.
入组人数: 32
试验地点: 1
主要终点: Tmax for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Other
盲法: None

入排标准

年龄范围: 18 Years 至 40 Years（Adult）
性别: Female
接受健康志愿者: 是

入选标准

•Healthy females, between 18 and 40 years of age inclusive
•BMI between 18.5 and 30.0 kg/m2, inclusive; total body weight of >110 lbs (50 kg);
•in good health, determined by no clinically significant or relevant abnormalities identified by a detailed medical history and physical exam
•no known history of hypersensitivity or previous intolerance to lomitapide or EE/norgestimate
•creatine phosphokinase, AST, and ALT levels must be below 1.5 times the upper limit of normal
•clinical laboratory evaluations within the reference range for the test laboratory
•negative test for selected drugs of abuse
•negative hepatitis panel and negative HIV antibody screens
•are of childbearing potential(ie, not postmenopausal or surgically sterile). All subjects must have a negative serum beta pregnancy test.
•able to comprehend and willing to sign an Informed Consent Form

排除标准

•significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, GI, neurological, or psychiatric disorder
•history of unexplained breast abnormalities or abnormal uterine bleeding
•history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
•history of stomach or intestinal surgery or resection
•history of Gilbert's Syndrome or suspicion of Gilbert's Syndrome
•subjects who have an abnormality in the 12-lead ECG
•use of any drugs of abuse for 6 months prior to Check-in;
•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
•use of any tobacco- or nicotine-containing products within 6 months prior to Check-in;
•participation in any other investigational study drug trial within 30 days prior to Check-in;
•use of any prescription medications/products within 14 days prior to Check-in unless deemed acceptable by the Investigator and Sponsor
•use of any over-the-counter, nonprescription preparations within 7 days prior to Check-in, unless deemed acceptable by the Investigator and Sponsor
•use of alcohol-, grapefruit- (including star fruit), or caffeine-containing foods or beverages within 72 hours prior to Check-in and through Study Completion
•use of oral (except scheduled administration of EE/norgestimate), implantable, injectable, or transdermal contraceptives
•use of hormone replacement therapy
•poor peripheral venous access;
•donation of blood (500 mL) from 30 days prior to Screening through Study Completion
•receipt of blood products within 2 months prior to Check-in;
•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;
•subjects who, in the opinion of the Investigator, should not participate in this study.

研究组 & 干预措施

Arm 1: Lomitapide & EE/Norgestimate - Taken Together

Experimental

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)

干预措施: lomitapide (Drug)

Arm 1: Lomitapide & EE/Norgestimate - Taken Together

Experimental

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)

干预措施: EE/norgestimate (Drug)

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

Experimental

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)

干预措施: lomitapide (Drug)

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

Experimental

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)

干预措施: EE/norgestimate (Drug)