CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 26 enrolled
Drug / intervention
Abemaciclib +1 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/NCT02117648
NCT02117648Phase 1Completed
CompareCT.gov

Effects of CYP3A Inhibition by Clarithromycin on the Pharmacokinetics of LY2835219 and Its Metabolites in Cancer Patients

Eli Lilly and Company·interventional·Posted Apr 21, 2014·Updated Jan 7, 2019

In Brief

A Phase 1 clinical trial evaluating Abemaciclib and Clarithromycin for Neoplasm and Neoplasm Metastasis. Completed, enrolled 26 participants across 2 sites.

Detailed Summary

The purpose of this study is to assess how the body handles Abemaciclib when it is given with another drug called clarithromycin. The study doctor will measure the amount of Abemaciclib that is absorbed into the blood stream and the time that it takes to remove Abemaciclib from the body. The safety and tolerability of these drugs will be studied. Each participant will complete 2 study periods in fixed order. After screening, Period 1 will last approximately 8 days and Period 2 will last approximately 15 days. Participants who complete Period 2 may continue to receive Abemaciclib in 28-day cycles until discontinuation criteria are met.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasm, Neoplasm Metastasis
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 21, 2014
Enrollment StartApr 1, 2014
Primary CompletionFeb 1, 2015
Study CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 12.2 years ago

Interventions

Abemaciclibdrug

Administered orally

Clarithromycindrug

Administered orally