drugset / Trial / NCT06215430
A Study of Effect of Multiple Doses of LOXO-305 on the Pharmacokinetics of Single Oral Doses of CYP1A2, CYP2C9, CYP2C19 Substrates in Healthy Participants
Non-randomizedSequentialOpen-labelBasic science
Summary
The main purpose of this study is to evaluate the effect of LOXO-305 on single oral dose of caffeine cytochrome P450 1A2 (CYP1A2) substrate, S-warfarin (CYP2C9 substrate), and omeprazole (CYP2C19 substrate) when administered as multiple doses by collecting the blood samples and conducting the blood tests to measure how much LOXO-305 is in the bloodstream and how the body handles and eliminates LOXO-305 in adult healthy participants. The study will also evaluate the safety and tolerability of LOXO-305. The study will be conducted in two periods. Participants will stay in this study for up to 67 days, including screening.
Timeline
- Start
- 2021-01-11
- Primary completion
- 2021-04-15
- Completion
- 2021-04-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Caffeine | Small molecule | 200 mg | Oral |
| Subject | Omeprazole | Other / unclassified | 40 mg | Oral |
| Subject | Pirtobrutinib | Other / unclassified | 200 mg | Oral |
| Subject | Warfarin | Small molecule | 10 mg | Oral |
Indications
No indication recorded.