MedTrace Logo

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

NCT01358968 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-10-25

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

LY2603618

Administered intravenously as a 1-hour infusion.

DRUG

Desipramine

Administered orally

DRUG

Pemetrexed

Administered intravenously as a 10-minute infusion.

DRUG

Gemcitabine

Administered intravenously as a 30-minute infusion.

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-371-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-04-30
Completion
2012-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01358968 on ClinicalTrials.gov