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

NCT ID: NCT02540668

Last Updated: 2019-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-01-31

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.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Warfarin

Single oral dose of 15 mg warfarin on Day 1.

Group Type: EXPERIMENTAL

Warfarin

Intervention Type: DRUG

Administered orally

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.

Group Type: EXPERIMENTAL

Lanabecestat

Intervention Type: DRUG

Administered orally

Warfarin

Intervention Type: DRUG

Administered orally

Interventions

Lanabecestat

Administered orally

Intervention Type: DRUG

Warfarin

Administered orally

Intervention Type: DRUG

Other Intervention Names

LY3314814; AZD3293

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Covance Clinical Research Inc

Evansville, Indiana, United States

Countries

United States

Other Identifiers

I8D-MC-AZEO

Identifier Type: OTHER

Identifier Source: secondary_id

16008

Identifier Type: -

Identifier Source: org_study_id