CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 48 enrolled
Drug / intervention
Drug Cocktail +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/NCT02688088
NCT02688088Phase 1Completed
CompareCT.gov

Effects of Multiple Doses of Abemaciclib on the Pharmacokinetics of Cytochrome P450 (CYP) 1A2, CYP2C9, CYP2D6, and CYP3A Substrates (Caffeine, Warfarin, Dextromethorphan, and Midazolam) in Cancer Patients

Eli Lilly and Company·interventional·Posted Feb 23, 2016·Updated Oct 18, 2022

In Brief

A Phase 1 clinical trial evaluating Drug Cocktail and Abemaciclib for Neoplasm Metastasis. Completed, enrolled 48 participants across 5 sites.

Detailed Summary

This study is known as a "drug interaction study" and is being done to see how abemaciclib may affect the blood levels of a drug mixture of commonly used drugs (caffeine, warfarin, dextromethorphan, and midazolam) when taken in combination with abemaciclib. Each participant will complete screening and four study periods in a fixed sequence, with the option to continue to receive abemaciclib in a safety extension phase. All participants will complete a safety follow-up.

Study Details

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

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 23, 2016
Enrollment StartMar 8, 2016
Primary CompletionFeb 4, 2018
Study CompletionJan 6, 2021
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 10.4 years ago

Interventions

Drug Cocktaildrug

Administered orally

Abemaciclibdrug

Administered orally