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Trial record 2 of 19 for:    lomitapide

Evaluate the Effect of Ethinyl Estradiol/Norgestimate on the Pharmacokinetics of Lomitapide in Healthy Female Subjects

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ClinicalTrials.gov Identifier: NCT02080468
Recruitment Status : Completed
First Posted : March 6, 2014
Results First Posted : March 11, 2019
Last Update Posted : March 11, 2019
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
Results First Submitted Date  ICMJE June 23, 2015
Results First Posted Date  ICMJE March 11, 2019
Last Update Posted Date March 11, 2019
Actual Study Start Date  ICMJE February 19, 2014
Actual Primary Completion Date April 24, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2018)
  • Cmax for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together) [ Time Frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing ]
    Maximum observed plasma concentration of lomitapide and its 2 primary metabolites, M1 & M3
  • Tmax for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together) [ Time Frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing ]
    Time to reach maximum observed plasma concentration of lomitapide and its 2 primary metabolites, M1 & M3.
  • AUC0-t for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together) [ Time Frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing ]
    Area under the concentration-time curve from zero to last quantifiable concentration of lomitapide and its 2 primary metabolites, M1 & M3.
  • AUC0-∞ for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together) [ Time Frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing ]
    Area under the concentration-time curve from zero to infinity of lomitapide and its 2 primary metabolites, M1 & M3.
  • t1/2 for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together) [ Time Frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing ]
    Apparent terminal elimination half-life of lomitapide and its 2 primary metabolites, M1 & M3.
Original 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2018)
  • Cmax for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart) [ Time Frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing ]
    Maximum observed plasma concentration of lomitapide and its metabolites, M1 & M3.
  • Tmax for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart) [ Time Frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing ]
    Time to reach maximum observed plasma concentration of lomitapide and its metabolites, M1 & M3.
  • AUC0-t for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart) [ Time Frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing ]
    Area under the concentration-time curve from zero to last quantifiable concentration of lomitapide and its metabolites, M1 & M3.
  • AUC0-∞ for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart) [ Time Frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing ]
    Area under the concentration-time curve from zero to infinity of lomitapide and its metabolites, M1 & M3.
  • t1/2 for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart) [ Time Frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing ]
    Apparent terminal elimination half-life of lomitapide and its metabolites, M1 & M3.
Original 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
  • λz [ 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 rate constant
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 Ethinyl Estradiol/Norgestimate on the Pharmacokinetics of Lomitapide in Healthy Female Subjects
Official Title  ICMJE A Phase 1, Open-Label, Randomized, 2-Arm Study to Evaluate the Effect of Ethinyl Estradiol/Norgestimate (Ortho Cyclen®), a Weak CYP3A4 Inhibitor, on the Pharmacokinetics of Lomitapide in Healthy Female Subjects
Brief Summary The primary objective of this study is to assess the effect of ethinyl estradiol (EE)/norgestimate, a weak cytochrome P450 (CYP) 3A4 inhibitor, on the pharmacokinetics (PK) of lomitapide and 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 EE/norgestimate, a weak CYP3A4 inhibitor, on the PK of lomitapide in healthy female subjects when EE/norgestimate is administered simultaneously with lomitapide and when administration is separated by 12 hours.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: lomitapide
    20 mg
    Other Name: Juxtapid
  • Drug: EE/norgestimate
    1x0.035-mg EE/0.25-mg norgestimate tablet
    Other Name: Ortho Cylclen
Study Arms  ICMJE
  • Experimental: Arm 1: Lomitapide & EE/Norgestimate - Taken Together
    Lomitapide & EE/Norgestimate - Taken Together 2 single oral doses of lomitapide (20 mg) (Day 1 & Day 22) 21 single oral doses of EE/Norgestimate(Day 8 through day 28)
    Interventions:
    • Drug: lomitapide
    • Drug: EE/norgestimate
  • Experimental: Arm 2: Lomitapide & EE/Norgestimate - Taken 12 Hours Apart
    Lomitapide & EE/Norgestimate - Taken 12 hours apart 2 single oral doses of lomitapide (20 mg) (Day 1 & Day 22) 21 single oral doses of EE/Norgestimate(Day 9 through day 29)
    Interventions:
    • Drug: lomitapide
    • Drug: EE/norgestimate
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
Actual Enrollment  ICMJE
 (submitted: March 5, 2014)
32
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 24, 2014
Actual Primary Completion Date April 24, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy females, between 18 and 40 years of age inclusive
  2. BMI between 18.5 and 30.0 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 and physical exam
  4. no known history of hypersensitivity or previous intolerance to lomitapide or EE/norgestimate
  5. creatine phosphokinase, AST, and ALT levels must be below 1.5 times the upper limit of normal
  6. clinical laboratory evaluations within the reference range for the test laboratory
  7. negative test for selected drugs of abuse
  8. negative hepatitis panel and negative HIV antibody screens
  9. are of childbearing potential(ie, not postmenopausal or surgically sterile). All subjects must have a negative serum beta pregnancy test.
  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 unexplained breast abnormalities or abnormal uterine bleeding
  3. history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
  4. history of stomach or intestinal surgery or resection
  5. history of Gilbert's Syndrome or suspicion of Gilbert's Syndrome
  6. subjects who have an abnormality in the 12-lead ECG
  7. use of any drugs of abuse for 6 months prior to Check-in;
  8. 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
  9. use of any tobacco- or nicotine-containing products within 6 months prior to Check-in;
  10. participation in any other investigational study drug trial within 30 days prior to Check-in;
  11. use of any prescription medications/products within 14 days prior to Check-in unless deemed acceptable by the Investigator and Sponsor
  12. use of any over-the-counter, nonprescription preparations within 7 days prior to Check-in, unless deemed acceptable by the Investigator and Sponsor
  13. use of alcohol-, grapefruit- (including star fruit), or caffeine-containing foods or beverages within 72 hours prior to Check-in and through Study Completion
  14. use of oral (except scheduled administration of EE/norgestimate), implantable, injectable, or transdermal contraceptives
  15. use of hormone replacement therapy
  16. poor peripheral venous access;
  17. donation of blood (500 mL) from 30 days prior to Screening through Study Completion
  18. receipt of blood products within 2 months prior to Check-in;
  19. 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;
  20. subjects who, in the opinion of the Investigator, should not participate in this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 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 NCT02080468
Other Study ID Numbers  ICMJE AEGR-733-029
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 November 2018

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