Evaluate the Effect of Atorvastatin on the Pharmacokinetics of Lomitapide in Healthy Subjects.
Information source: Aegerion Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Effect of Atorvastatin on the Pharmacokinetics of Lomitapide
Intervention: lomitapide (Drug); Atorvastatin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Aegerion Pharmaceuticals, Inc. Official(s) and/or principal investigator(s): Mark Sumeray, MD, Study Chair, Affiliation: Cheif Medical Officer T. Alex King, MD, CPI, Principal Investigator, Affiliation: Covance Clinical Research Unit Inc.
Summary
The primary objective of this study is to assess the effect of atorvastatin, a weak
cytochrome P450 (CYP) 3A4 inhibitor, on the pharmacokinetics (PK) of lomitapide and its 2
primary metabolites, M1 and M3.
Clinical Details
Official title: A Phase 1, Open-Label, Randomized, 2-Arm Study to Evaluate the Effect of Atorvastatin, a Weak CYP3A4 Inhibitor, on the Pharmacokinetics of Lomitapide in Healthy Subjects
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
Primary outcome: AUC0-t
Secondary outcome: Cmaxtmax t1/2 AUC0-∞
Detailed description:
This study will be a single center, randomized, open-label, 2-arm study to evaluate the
effects of atorvastatin, a weak CYP3A4 inhibitor, on the PK of lomitapide in healthy male
and female subjects when atorvastatin is administered simultaneously with lomitapide and
when it is administered 12 hours after lomitapide.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Healthy males and females, between 18 and 55 years of age inclusive
2. BMI between 18. 5 and 32. 0 kg/m2, inclusive; total body weight of >110 lbs (50 kg);
3. in good health, determined by no clinically significant or relevant abnormalities
identified by a detailed medical history
4. creatine phosphokinase, AST, and ALT levels must be below 1. 5 times the upper limit
of normal
5. clinical laboratory evaluations within the reference range for the test laboratory
6. negative test for selected drugs of abuse
7. negative hepatitis panel and negative HIV antibody screens
8. males will either be sterile or agree to use approved methods of contraception
9. all females must have a negative serum beta human chorionic gonadotropin pregnancy
test and will be required to use a medically acceptable method of contraception.
10. able to comprehend and willing to sign an Informed Consent Form
Exclusion Criteria:
1. significant history or clinical manifestation of any metabolic, allergic,
dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, GI,
neurological, or psychiatric disorder
2. history of significant hypersensitivity, intolerance, or allergy to any drug
compound, food, or other substance
3. history of stomach or intestinal surgery or resection
4. history of Gilbert's Syndrome or suspicion of Gilbert's Syndrome
5. subjects who have an abnormality in the 12-lead ECG
6. use of any drugs of abuse for 6 months prior to Check-in;
7. subjects who consume more than 14 units of alcohol per week or who have a significant
history of alcoholism or drug/chemical abuse within 1 year prior to Check-in
8. use of any tobacco- or nicotine-containing products within 6 months prior to
Check-in;
9. participation in any other investigational study drug trial within 30 days prior to
Check-in;
10. use of any prescription medications/products within 14 days prior to Check-in unless
deemed acceptable by the Investigator and Sponsor
11. use of any over-the-counter, nonprescription preparations within 7 days prior to
Check-in, unless deemed acceptable by the Investigator and Sponsor
12. use of alcohol-, grapefruit- (including star fruit), or caffeine-containing foods or
beverages within 72 hours prior to Check-in and through Study Completion
13. poor peripheral venous access;
14. donation of blood (500 mL) from 30 days prior to Screening through Study Completion
15. receipt of blood products within 2 months prior to Check-in;
16. any acute or chronic condition, scheduled hospitalization (inclusive of elective
surgery during study) or scheduled travel prior to completion of all study procedures
which, in the opinion of the Investigator, would limit the subject's ability to
complete and/or participate in this clinical study;
17. subjects who, in the opinion of the Investigator, should not participate in this
study.
Locations and Contacts
Covance Clinical Research Unit, Inc, Dallas, Texas 75247, United States
Additional Information
Starting date: February 2014
Last updated: March 23, 2015
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