drugset / Trial / NCT01358968

A Drug Interaction Study to Assess the Effect of LY2603618 on the Metabolic Pathway of Desipramine

NCT01358968

Phase 1 Completed 20 enrolled Eli Lilly and Company
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the effect LY2603618 on a protein \[enzyme cytochrome P (CYP) 2D6\] which is involved in the metabolic pathway of Desipramine in participants with cancer. This is a drug interaction study so the treatment of the disease will not be the main purpose of the study. The study involves two single doses of 50 milligrams (mg), 1 tablet by mouth, on Day 1 of Period 1 and 2. In Period 1 Desipramine will be administered alone. In Period 2 Desipramine will be administered in combination with LY2603618. LY2603618 will be administered as a 275mg intravenous (IV) infusion over 1 hour (hr). Desipramine will be administered at the end of the LY2603618 infusion. Information about any side effects that may occur will also be collected.

Timeline

Start
2011-06
Primary completion
2012-04
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Desipramine Small molecule 50 mg Oral
Subject RABUSERTIB Small molecule 230 mg Intravenous
Subject RABUSERTIB Small molecule 275 mg Intravenous
Background Gemcitabine Small molecule 1000 mg/m2 Intravenous
Background Pemetrexed Small molecule 500 mg/m2 Intravenous

Indications