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Evaluate the Effect of Atorvastatin on the Pharmacokinetics of Lomitapide in Healthy Subjects.

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ClinicalTrials.gov Identifier: NCT02080455
Recruitment Status : Completed
First Posted : March 6, 2014
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):
Aegerion Pharmaceuticals, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Effect of Atorvastatin on the Pharmacokinetics of Lomitapide Drug: lomitapide Drug: Atorvastatin Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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 Start Date : February 2014
Actual Primary Completion Date : March 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lomitapide & Atorvastatin - Taken Together

2 single oral doses of lomitapide (20 mg) with a 14-day washout between (Day 1 & Day 15)

11 single oral doses of atorvastatin (80 mg) (Day 11 through day 21)

Drug: lomitapide
20 mg dose
Other Name: Juxtapid

Drug: Atorvastatin
80 mg
Other Name: Lipitor

Experimental: Lomitapide & Atorvastatin - Approx. 12 hours between

2 single oral doses of lomitapide (20 mg) with a 14-day washout between (Day 1 & Day 15)

11 single oral doses of atorvastatin (80 mg) (Day 12 through day 22)

Drug: lomitapide
20 mg dose
Other Name: Juxtapid

Drug: Atorvastatin
80 mg
Other Name: Lipitor




Primary Outcome Measures :
  1. AUC0-t [ Time Frame: predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing. ]
    area under the concentration-time curve from 0 to the last measurable concentration


Secondary Outcome Measures :
  1. Cmax [ Time Frame: Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing. ]
    time to maximum concentration

  2. tmax [ Time Frame: Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing. ]
    time to maximum observed concentration

  3. t1/2 [ Time Frame: Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing. ]
    apparent terminal elimination half-life

  4. AUC0-∞ [ Time Frame: Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing. ]
    area under the concentration-time curve extrapolated to infinity



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02080455


Locations
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United States, Texas
Covance Clinical Research Unit, Inc
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Aegerion Pharmaceuticals, Inc.
Investigators
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Study Chair: Mark Sumeray, MD Cheif Medical Officer
Principal Investigator: T. Alex King, MD, CPI Covance

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Responsible Party: Aegerion Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02080455    
Other Study ID Numbers: AEGR-733-024
First Posted: March 6, 2014    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: January 2014
Additional relevant MeSH terms:
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Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors