drugset / Trial / NCT02688088
A Study of Abemaciclib in Participants With Cancer That is Advanced or Has Spread to Another Part(s) of the Body
Non-randomizedSingle-groupOpen-labelBasic science
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.
Timeline
- Start
- 2016-03-08
- Primary completion
- 2018-02-04
- Completion
- 2021-01-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abemaciclib | Small molecule | 200 mg | Oral |
| Subject | Caffeine | Small molecule | 100 mg | Oral |
| Subject | Dextromethorphan | Unknown | 30 mg | Oral |
| Subject | Midazolam | Small molecule | 0.2 mg | Oral |
| Subject | Warfarin | Small molecule | 10 mg | Oral |