A trial to compare lomitapide at different doses with placebo with regards to safety, what the drug does, and where the drug goes, in Japanese and Caucasian volunteers who have higher then normal cholesterol levels

• Conditions: Persons with elevated low-density-lipoprotein - cholesterol levels (at least 110 mg/dL).; MedDRA version: 14.1Level: LLTClassification code 10024055Term: LDL cholesterol increasedSystem Organ Class: 100000004848; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2012-004220-37-GB
• Lead Sponsor: Aegerion Pharmaceuticals Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-17
• Last Update Posted: 10 March 2014

Recruitment & Eligibility

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

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

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.

Study & Design

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