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NCT06180967 · ClinicalTrials.gov registry record · Phase 1
A Drug Drug Interaction (DDI) Study of Pirtobrutinib (LOXO-305) and Different Formulations of Midazolam in Healthy Participants
A Phase 1 study of Healthy, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT06180967: Completed Phase 1 study of Healthy, sponsored by Eli Lilly and Company.
NCT06180967 is a Phase 1 study of Healthy that has completed, run by Eli Lilly and Company. The registered enrollment target is 15 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06180967, a Phase 1 study of Healthy, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
The main purpose of this study is to assess the effect of Pirtobrutinib (LOXO-305) on how fast different formulations of midazolam gets into the blood stream and how long it takes the body to remove it when administered in healthy participants. The study will also access how much endogenous coproporphyrins I and III as biomarkers of OATP1B1 and OATP1B3 is in the bloodstream and how the body handles and eliminates them following single and multiple oral doses of Pirtobrutinib. Safety and tolerability of Pirtobrutinib will also be evaluated. For each participant, the total duration of the study will be 59 days, including screening.
Primary Outcome
PK: AUC0-t of midazolam and its metabolite 1-OH-midazolam following oral dose administration was reported.
Conditions Studied
Interventions
- DRUG Pirtobrutinib
- DRUG Midazolam Syrup
- DRUG Midazolam Solution
Study Locations (1)
Florida
- Covance Clinical Research Unit - Daytona Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2020-09-03 |
| Est. Completion | 2020-10-20 |
| Phase | Phase 1 |
What the finished NCT06180967 record still lists
NCT06180967 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 3 interventions - of which Pirtobrutinib is the first listed.
NCT06180967 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT06180967 about?
NCT06180967 is a clinical study titled "A Drug Drug Interaction (DDI) Study of Pirtobrutinib (LOXO-305) and Different Formulations of Midazolam in Healthy Participants". The main purpose of this study is to assess the effect of Pirtobrutinib (LOXO-305) on how fast different formulations of midazolam gets into the blood stream and how long it takes the body to remove it when administered in healthy participants. The study will also access how much endogenous copropor...
What is the current status of trial NCT06180967?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2020-09-03. Estimated completion is 2020-10-20.
What conditions does trial NCT06180967 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT06180967?
The interventions under investigation include: Pirtobrutinib (DRUG), Midazolam Syrup (DRUG), Midazolam Solution (DRUG).
Who is sponsoring clinical trial NCT06180967?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06180967 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06180967's enrollment target sits among peer trials
15 955th of 1090 higher than 118 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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.
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