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NCT06180954 · ClinicalTrials.gov registry record · Phase 1
A Study of Carbon-14-Labelled [14C] LOXO-305 (Pirtobrutinib) in Healthy Male Participants
A Phase 1 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT06180954 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 9 participants.
The verdict
NCT06180954, a Phase 1 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
The main purpose of this study is to evaluate the absorption, metabolism, and excretion (AME) profiles of pirtobrutinib (LOXO-305), to identify and characterize metabolites of pirtobrutinib (LOXO-305), and to assess the safety and tolerability of \[14C\] LOXO-305 in Part 1. To determine the absolute bioavailability of pirtobrutinib (LOXO-305), to evaluate the plasma concentration of total radioactivity, to evaluate the urinary excretion of \[14C\] LOXO-305 and total radioactivity, to evaluate the fecal excretion of \[14C\] LOXO-305 and total radioactivity, and to assess the safety and tolerability of pirtobrutinib (LOXO-305), and \[14C\] LOXO-305 in Part 2. Blood tests will be performed to check how much pirtobrutinib (LOXO-305) and \[14C\] LOXO-305 gets into the bloodstream and how long it takes the body to eliminate it. The study will last up to approximately 60 days for Part 1 and approximately 47 days for Part 2.
Interventions
- DRUG LOXO-305
- DRUG [14C]-LOXO-305
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2020-09-23 |
| Est. Completion | 2020-11-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06180954
The ClinicalTrials.gov registry entry for NCT06180954 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 9 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 2 interventions - of which LOXO-305 is the first listed.
NCT06180954 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06180954 about?
NCT06180954 is a clinical study titled "A Study of Carbon-14-Labelled [14C] LOXO-305 (Pirtobrutinib) in Healthy Male Participants". The main purpose of this study is to evaluate the absorption, metabolism, and excretion (AME) profiles of pirtobrutinib (LOXO-305), to identify and characterize metabolites of pirtobrutinib (LOXO-305), and to assess the safety and tolerability of \[14C\] LOXO-305 in Part 1. To determine the absolute...
What is the current status of trial NCT06180954?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2020-09-23. Estimated completion is 2020-11-06.
What interventions are being tested in trial NCT06180954?
The interventions under investigation include: LOXO-305 (DRUG), [14C]-LOXO-305 (DRUG).
Who is sponsoring clinical trial NCT06180954?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
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