drugset / Trial / NCT01388335

A Drug Interaction Study to Assess the Effect of LY317615 on the Metabolic Pathway of Warfarin

NCT01388335

Phase 1 Completed 13 enrolled Eli Lilly and Company
CrossoverOpen-labelOther

Summary

The purpose of this study is to assess the effect of enzastaurin (LY317615), on a protein (enzyme CYP2C9) which is involved in the metabolic pathway of warfarin in participants with solid tumors or lymphomas. Information about any side effects that may occur will also be collected. This is a drug interaction study so the treatment of the disease will not be the main purpose of the study. This is a Phase 1, open label, fixed sequence, 2 period study conducted in participants with solid tumors or lymphomas. The duration of participation in this study will be up to approximately 38 days not including screening, after which participants will be allowed to continue receiving enzastaurin. There is no planned duration for the extension phase of this study; participants will be allowed to continue to receive enzastaurin until fulfilling one of the criteria for discontinuation, such as unacceptable toxicity or disease progression.

Timeline

Start
2011-08
Primary completion
2012-10
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Warfarin Small molecule 5 mg Oral
Subject enzastaurin Small molecule 500 mg Oral

Indications