Phase 1
Completed N=15
A Drug Interaction Study of Lanabecestat (LY3314814) and Warfarin in Healthy Participants
Healthy
Source: ClinicalTrials.gov NCT02540668 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcomePrimary: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Unbound S-Warfarin — 3.50; 3.73 nanogram per milliliter (ng/mL)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Maximum Concentration (Cmax) of Unbound S-Warfarin |
3.50; 3.73 | — |
| PRIMARY Pharmacokinetics (PK): Area Under the Concentration Curve 0-∞ (AUC) of Unbound S-Warfarin |
108; 123 | — |
| SECONDARY Pharmacokinetics (PK): Maximum Concentration (Cmax) of Unbound R-Warfarin |
4.45; 4.80 | — |
| SECONDARY Pharmacokinetics (PK): Area Under The Concentration Curve 0-∞(AUC) of Unbound R-Warfarin |
262; 296 | — |
| SECONDARY Pharmacodynamics (PD): Area Under the International Normalized Ratio (INR) Versus Time Curve (AUCINR) of Warfarin |
160; 158 | — |
| SECONDARY Pharmacodynamics (PD): Maximum Observed INR Response (INRmax) of Warfarin |
1.29; 1.26 | — |
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
Data sourced from ClinicalTrials.gov (NCT02540668). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.