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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE March 5, 2014
First Posted Date  ICMJE March 6, 2014
Last Update Posted Date March 24, 2015
Study Start Date  ICMJE February 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2014)
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate the Effect of Atorvastatin on the Pharmacokinetics of Lomitapide in Healthy Subjects.
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Effect of Atorvastatin on the Pharmacokinetics of Lomitapide
Intervention  ICMJE
  • Drug: lomitapide
    20 mg dose
    Other Name: Juxtapid
  • Drug: Atorvastatin
    80 mg
    Other Name: Lipitor
Study Arms  ICMJE
  • 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)

    Interventions:
    • Drug: lomitapide
    • Drug: Atorvastatin
  • 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)

    Interventions:
    • Drug: lomitapide
    • Drug: Atorvastatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 5, 2014)
32
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02080455
Other Study ID Numbers  ICMJE AEGR-733-024
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Aegerion Pharmaceuticals, Inc.
Study Sponsor  ICMJE Aegerion Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Mark Sumeray, MD Cheif Medical Officer
Principal Investigator: T. Alex King, MD, CPI Covance
PRS Account Aegerion Pharmaceuticals, Inc.
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP