Trials / Completed

CompletedNCT02688088

A Study of Abemaciclib in Participants With Cancer That is Advanced or Has Spread to Another Part(s) of the Body

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

Status: Completed
Phase: Phase 1
Study type: Interventional
Enrollment: 48 (actual)

Sponsor: Eli Lilly and Company · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Conditions

Neoplasm Metastasis

Interventions

Type	Name	Description
DRUG	Drug Cocktail	Administered orally
DRUG	Abemaciclib	Administered orally

Timeline

Start date: 2016-03-08
Primary completion: 2018-02-04
Completion: 2021-01-06
First posted: 2016-02-23
Last updated: 2022-10-18
Results posted: 2022-10-18

Locations

5 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02688088. Inclusion in this directory is not an endorsement.