Persons with elevated low-density-lipoprotein - cholesterol levels (at least 110 mg/dL). MedDRA version: 14.1 Level: LLT Classification code 10024055 Term: LDL cholesterol increased System Organ Class: 100000004848
Conditions
Sponsors
Aegerion Pharmaceuticals Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy male and female Caucasian or Japanese aged 20-45 years. Body mass index of 18.5-30 kg/m*2 at screening. Low density lipoprotein cholesterol level of at least 110 mg/dL. Agree to use acceptable contraception from the time of signing the informed consent until 3 months following administration of the last treatment or dose of study medication . Agree to comply with the requirements of the protocol. 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 104 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Clinically significant disease or condition which might affect drug absorption, distribution or excretion. Any clinically significant laboratory abnormality, vital signs or other safety finding. Clinically significant electrocardiogram abnormalities. Positive hepatitis or HIV serology tests. Positive urine drug screen results. Positive serum ß-HCG and urine pregnancy test or lactating. History of alcohol or drug abuse. Metal handicap. Patients with dietary restrictions conflicting with the study standardised menus. Participation in a drug trial within 90 days prior to first drug administration. Use of any medication (including over-the-counter) within 2 weeks prior to enrolment. Use of any substance inhibiting cytochrome P450 within 2 weeks prior to enrolment. Donation of more than 500 mL of blood within 90 days prior to enrolment. Smoking more than 10 cigarettes (or equivalent amount of tobacco) per day and/or inability to cease smoking for the duration of the study. Treatment with herbal supplements 7 days prior to dosing, or use of vitamins 48 hours prior to enrolment. Legal incapacity or limited legal capacity at screening. Any circumstances or conditions which, in the opinion of the investigator, may affect full participation in the trial or compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the pharmacokinetics of lomitapide and its M1 and M3 metabolites between Japanese and Caucasian subjects with elevated LDL-C after single and multiple doses across the range studied.;Secondary Objective: To assess the single dose and multiple dose safety, tolerability and pharmacodynamics of lomitapide in Japanese and Caucasian subjects with elevated LDL-C;Primary end point(s): Pharmacokinetic: Maximum plasma concentration. Area under the plasma concentration vs time curve from zero to the last quantifiable concentration. Area under the plasma concentration vs time curve from zero to infinity. Pharmacodynamic: HDL, LDL, VLDL, total cholesterol, lipoprotein (a) and apolipoprotein B.;Timepoint(s) of evaluation of this end point: Pharmacokinetic: Days 1, 2, 3, 4, 5, 6 and 7. Pharmacodynamic: Pre-dose on Days -1, 5, 6, 7, 13, 18, 20, 22, 24, 27 and post-dose on Day 27. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pharmacokinetic: Time to maximum plasma concentration. Half life. Pharmacodynamic: Total triglycerides.;Timepoint(s) of evaluation of this end point: Pharmacokinetic: Days 1, 2, 3, 4, 5, 6 and 7. Pharmacodynamic: Pre-dose on Days -1, 5, 6, 7, 13, 18, 20, 22, 24, 27 and post-dose on Day 27. | — |
Countries
United Kingdom
Contacts
Public ContactRichmond Pharmacology Ltd
Richmond Pharmaceuticals Ltd
Outcome results
None listed