CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 20 enrolled
Drug / intervention
LY2603618 +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01358968
NCT01358968Phase 1Completed

A Study in Cancer Patients to Evaluate the Ability of LY2603618 to Act as an Inhibitor of CYP2D6 Using Desipramine as a Probe Substrate

Eli Lilly and Company·interventional·Posted May 24, 2011·Updated Oct 25, 2018

In Brief

A Phase 1 clinical trial evaluating LY2603618, Desipramine, and 2 other interventions for Cancer. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 24, 2011
Enrollment StartJun 1, 2011
Primary CompletionApr 1, 2012
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 15.1 years ago

Interventions

LY2603618drug

Administered intravenously as a 1-hour infusion.

Desipraminedrug

Administered orally

Pemetrexeddrug

Administered intravenously as a 10-minute infusion.

Gemcitabinedrug

Administered intravenously as a 30-minute infusion.