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A Drug Interaction Study of Lanabecestat (LY3314814) and Warfarin in Healthy Participants

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ClinicalTrials.gov Identifier: NCT02540668
Recruitment Status : Completed
First Posted : September 4, 2015
Results First Posted : March 25, 2019
Last Update Posted : March 25, 2019
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The purpose of this study is to look at how much warfarin gets into the blood stream and how long it takes the body to get rid of it when given both with and without lanabecestat. Another purpose is to evaluate the effectiveness of warfarin therapy to prevent blood clots when given with lanabecestat by measuring international normalized ratio (INR). INR measures the time it takes for blood to clot and compares it to an average. Information about any side effects that may occur will also be collected. The study will last about 5 weeks from the first dose to follow-up for each participant.

Condition or disease Intervention/treatment Phase
Healthy Drug: Lanabecestat Drug: Warfarin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of LY3314814 on the Pharmacokinetics of Warfarin in Healthy Subjects
Study Start Date : September 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Experimental: Warfarin
Single oral dose of 15 mg warfarin on Day 1.
Drug: Warfarin
Administered orally

Experimental: Lanabecestat + Warfarin
Lanabecestat administered orally once daily on Days 8 to 27, with a single oral dose of 15 mg warfarin co-administered on Day 22.
Drug: Lanabecestat
Administered orally
Other Names:
  • LY3314814
  • AZD3293

Drug: Warfarin
Administered orally




Primary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Unbound S-Warfarin [ Time Frame: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22 ]
  2. Pharmacokinetics (PK): Area Under the Concentration Curve 0-∞ (AUC) of Unbound S-Warfarin [ Time Frame: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22 ]

Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Unbound R-Warfarin [ Time Frame: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22 ]
  2. Pharmacokinetics (PK): Area Under The Concentration Curve 0-∞(AUC) of Unbound R-Warfarin [ Time Frame: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96,120, and 144 hours after administration of warfarin on Days 1 and 22 ]
  3. Pharmacodynamics (PD): Area Under the International Normalized Ratio (INR) Versus Time Curve (AUCINR) of Warfarin [ Time Frame: Predose, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22 ]
  4. Pharmacodynamics (PD): Maximum Observed INR Response (INRmax) of Warfarin [ Time Frame: Predose, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male participants: will be sterile (including vasectomy) or agree to use an effective method of birth control and will not donate sperm during the study and for 3 months following the last dose of the investigational product
  • Female participants: women not of childbearing potential

Exclusion Criteria:

  • Have a history of or current, significant ophthalmic disease, as determined by the investigator or ophthalmologist
  • Have vitiligo or any other clinically significant disorder of skin pigmentation as determined by the investigator or dermatologist
  • Have a history or presence of significant bleeding disorders
  • Have a history of gastrointestinal ulcers with hemorrhage
  • Have a personal or family history of coagulation or bleeding disorders or reasonable suspicion of vascular malformations
  • Self-reported history of increased bleeding from trauma
  • Have a history of major head trauma (with loss of consciousness) within the past year or minor head trauma (without loss of consciousness) within the last 3 months prior to screening
  • History of major surgery within 3 months of screening
  • Planned surgery within 14 days after the last day of dosing
  • International Normalized Ratio (INR)/ Prothrombin Time (PT) or activated partial thromboplastin time above the normal reference range at screening
  • Abnormal Protein S antigen and/or Protein C activity as determined by the investigator
  • History of deep vein thrombosis and/or pulmonary embolism

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): NCT02540668


Locations
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United States, Indiana
Covance Clinical Research Inc
Evansville, Indiana, United States, 47710
Sponsors and Collaborators
Eli Lilly and Company
AstraZeneca
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02540668     History of Changes
Other Study ID Numbers: 16008
I8D-MC-AZEO ( Other Identifier: Eli Lilly and Company )
First Posted: September 4, 2015    Key Record Dates
Results First Posted: March 25, 2019
Last Update Posted: March 25, 2019
Last Verified: December 2018

Additional relevant MeSH terms:
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Warfarin
Anticoagulants