A study in healthy subjects to determine how the levels of drug in the blood vary following administration ofsingle oral capsule doses of 20 mg lomitapide on two separate occasions

• Conditions: Healthy volunteers; MedDRA version: 16.0Level: LLTClassification code 10024055Term: LDL cholesterol increasedSystem Organ Class: 100000004848; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2013-002692-17-GB
• Lead Sponsor: Aegerion Pharmaceuticals Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-03
• Last Update Posted: 17 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the intra-subject variability of the pharmacokinetics (PK) of single oral capsule doses of 20 mg lomitapide to determine the number of subjects to be dosed in future relative bioavailability studies;Secondary Objective: •To determine the number of subjects to be dosed in future relative bioavailability studies<br>•To evaluate the safety and tolerability of 20 mg lomitapide in healthy subjects ;Primary end point(s): Lomitapide pharmacokinetic parameters for lomitapide for each treatment period: maximum observed concentration, time to maximum observed concentration, apparent terminal elimination half-life, area under the concentration-time curve from hour 0 to the last measurable concentration, and area under the concentration-time curve extrapolated to infinity.;Timepoint(s) of evaluation of this end point: Samples to be collected on each treatment day: pre dose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post dose.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Safety assessments will include standard laboratory safety tests (haematology, biochemistry and urinalysis), vital signs (temperature, blood pressure and heart rate), physical examination, 12-lead ECG and adverse event monitoring. ;Timepoint(s) of evaluation of this end point: Standard laboratory safety tests will be performed at Screening and at protocol specified time points for each dosing period and on completion of the study. Vital sign, physical examination and ECG data will be collected at Screening and at protocol specified time points throughout the study.<br><br>Information on adverse events will be collected from the signing of the informed consent until the end of the study. Serious Adverse Events will be collected during the entire study period.