A Phase 1, Open-label, Crossover Study to Determine the intra-subject variability of the Pharmacokinetics of Single Oral Capsule Doses of 20 mg Lomitapide in Healthy Subjects

Aegerion Pharmaceuticals Inc0 个研究点开始时间: 2013年7月3日最近更新: 2014年2月17日

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试验速览

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•Male and female subjects will be included if they are healthy (for their age), 18 – 40 years (inclusive) of age, have a body mass index (BMI) of 18.5 to 25 kg/m² inclusive with a total body weight > 50 kg to = 100 kg, using an effective contraceptive method (if appropriate), and no known history of hypersensitivity or previous intolerance to lomitapide, applesauce, and/or Sprite®.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 15
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Use of any tobacco- or nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to admission (Day -1), subject has a clinically significant disease, allergy or clinically significant abnormal laboratory, ECG, vital signs or other safety findings as determined by medical history, physical examination or other evaluations conducted at screening or on admission, exclusion criteria for Gilbert’s syndrome, QTcF prolongation, history of prolonged QTc interval or Brugada syndrome also apply.

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