A Drug Interaction Study of Lanabecestat (LY3314814) and Warfarin in Healthy Participants
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 3/27/2019 |
| Start Date: | September 2015 |
| End Date: | January 2016 |
Effect of LY3314814 on the Pharmacokinetics of Warfarin in Healthy Subjects
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.
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.
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
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