NCT01388335

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

The Effect of Enzastaurin on CYP2C9: Enzastaurin - S-Warfarin Drug Interaction Study in Patients With Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor
• Lymphoma, Malignant

Interventions

Type	Name	Description
DRUG	warfarin	Administered orally
DRUG	enzastaurin	Administered orally

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-10-01
• Completion: 2012-12-01
• First posted: 2011-07-06
• Last updated: 2020-07-01
• Results posted: 2020-07-01

Locations

7 sites across 1 country: France