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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 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 16 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06215430
The ClinicalTrials.gov registry entry for NCT06215430 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Pirtobrutinib is the first listed.
NCT06215430 reports 0 study locations.
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.
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