Skip to main content
OpenTrials
Completed

NCT Number: NCT02540668

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Inc

Evansville, Indiana, 47710, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lanabecestat

Drug

Administered orally

Other names: LY3314814, AZD3293

Warfarin

Drug

Administered orally

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

Effect of LY3314814 on the Pharmacokinetics of Warfarin in Healthy Subjects

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 4, 2015
Registry last updated
Nov 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.