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NCT06215430 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT06215430: Completed Phase 1 study, sponsored by Eli Lilly and Company.
NCT06215430 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06215430, a Phase 1 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study 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.
Primary Outcome
Area under the concentration time curve (AUC) from hour 0 to 24 hours post-dose (AUC0-24) of caffeine was reported.
Interventions
- DRUG Pirtobrutinib
- DRUG Caffeine Tablet
- DRUG Omeprazole capsule
- DRUG Warfarin tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2021-01-11 |
| Est. Completion | 2021-04-15 |
| Phase | Phase 1 |
What the finished NCT06215430 record still lists
NCT06215430 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 4 interventions - of which Pirtobrutinib is the first listed.
NCT06215430 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06215430 about?
NCT06215430 is a clinical study titled "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". 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 ...
What is the current status of trial NCT06215430?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2021-01-11. Estimated completion is 2021-04-15.
What interventions are being tested in trial NCT06215430?
The interventions under investigation include: Pirtobrutinib (DRUG), Caffeine Tablet (DRUG), Omeprazole capsule (DRUG), Warfarin tablet (DRUG).
Who is sponsoring clinical trial NCT06215430?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06215430's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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