Status:
COMPLETED
Study to Determine the Intra-subject Variability of Pharmacokinetics of Lomitapide in Healthy Subjects
Lead Sponsor:
Aegerion Pharmaceuticals, Inc.
Conditions:
Intra-subject Variability of Pharmacokinetics
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief Summary
Objectives: To evaluate the intra-subject variability of the pharmacokinetics (PK) of single oral capsule doses of 20 mg lomitapide.
Detailed Description
This study will be a single centre, open-label study. It will comprise of 2 single oral doses with at least a 14-day washout between doses. Following the first dose subjects will be discharged from th...
Eligibility Criteria
Inclusion
- Subject is a non-smoking healthy male or female, aged between 18 and 40 years of age.
- Subject has a BMI of 18.5 - 25 kg/m2.
- Subject has total body weight between \> 50 kg to ≤ 100 kg.
- Subjects must agree to use acceptable methods of contraception.
- All females, regardless of childbearing potential, must have a negative serum beta human chorionic gonadotropin pregnancy test at Screening and on admission.
- In good health, determined by no clinically significant or relevant abnormalities identified by a detailed medical history \& full physical examination.
- No known history of hypersensitivity or previous intolerance to lomitapide.
- Subjects must be capable of understanding and complying with the requirements of the protocol and must have signed the informed consent form prior to undergoing any study-related procedures.
Exclusion
- Subject has a clinically significant disease or any condition or disease that might affect drug absorption, distribution or excretion.
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs.
- Any clinically significant abnormal laboratory, vital signs or other safety findings as determined by medical history, physical examination or other evaluations.
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator;
- Electrocardiogram (ECG) abnormalities in the standard 12-lead ECG (at screening) such as a QTcF interval of \>450 msec, a history of a prolonged QTc interval or Brugada syndrome.
- History or current evidence of any clinically relevant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, allergic, dermatological, metabolic, neurological, psychiatric or other disease.
- History or laboratory evidence of Gilbert's syndrome.
- Positive results in any of the serology tests for Hepatitis B Surface Antigen (HbsAg), anti-Hepatitis core antibody (anti-HBc Ig G \[and anti-HBc IgM if IgG is positive\], Hepatitis C antibodies (anti-HCV), and HIV 1 and 2 antibodies, (anti-HIV 1/2).
- Use of any drugs of abuse within 6 months prior to admission.
- Confirmed positive results from urine drug screen (amphetamines, benzodiazepines, cocaine, cannabinoids, opiates, barbiturates and methadone) or from the alcohol breath test at screening and on admission (Day -1).
- History or clinical evidence of alcohol or drug abuse within one year prior to admission.
- Mentally handicapped.
- Participation in a drug trial within 90 days prior to first drug administration.
- Use of any prescription medication within 2 weeks prior to admission (Day -1), with the exception of the oral contraceptive pill.
- Use of any substance inducing or inhibiting CYP3A4 enzymes within 30 days prior to admission (Day -1).
- Use of any over-the-counter (OTC) medication (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within 7 days prior to admission (Day -1), unless deemed acceptable by the Investigator and Sponsor.
- Use of alcohol-, grapefruit-, starfruit-, or caffeine-containing foods or beverages within 72 hours prior to admission and through Study Completion.
- Donation of more than 500 mL of blood within 90 days prior to drug administration.
- Receipt of blood products within 2 months prior to admission.
- Poor peripheral venous access.
- Use of any tobacco- or nicotine-containing products within 6 months prior to admission (Day -1).
- Any acute or chronic condition, scheduled hospitalisation (inclusive of elective surgery during study), or scheduled travel prior to completion of all study procedures.
- Any circumstances or conditions, which, in the opinion of the PI, may affect full participation in the trial or compliance with the protocol.
- Legal incapacity or limited legal capacity at screening.
- Subjects who are vegetarians, vegans or have any dietary restrictions conflicting with the study standardised menus.
Key Trial Info
Start Date :
July 29 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 23 2013
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01915771
Start Date
July 29 2013
End Date
August 23 2013
Last Update
March 11 2020
Active Locations (1)
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1
Richmond Pharmacology
Croydon, Surrey, United Kingdom, CR7 7YE