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NCT05509816 · ClinicalTrials.gov registry record · Phase 1
A Study of Imlunestrant (LY3484356) in Healthy Women
A Phase 1 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT05509816: Completed Phase 1 study, sponsored by Eli Lilly and Company.
NCT05509816 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05509816, a Phase 1 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
The main purpose of this study is to evaluate the effect of imlunestrant (LY3484356) when administered orally on the levels of midazolam in the blood stream in healthy women of non-childbearing potential. The study will also evaluate the safety and tolerability of imlunestrant in healthy women of non-childbearing potential. This study will last up to approximately 6 weeks for each participant including the screening period.
Primary Outcome
PK: AUC\[0-∞\] of Midazolam
Interventions
- DRUG Midazolam
- DRUG Imlunestrant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2022-09-12 |
| Est. Completion | 2022-11-30 |
| Phase | Phase 1 |
What the finished NCT05509816 record still lists
NCT05509816 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Midazolam is the first listed.
NCT05509816 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05509816 about?
NCT05509816 is a clinical study titled "A Study of Imlunestrant (LY3484356) in Healthy Women". The main purpose of this study is to evaluate the effect of imlunestrant (LY3484356) when administered orally on the levels of midazolam in the blood stream in healthy women of non-childbearing potential. The study will also evaluate the safety and tolerability of imlunestrant in healthy women of no...
What is the current status of trial NCT05509816?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2022-09-12. Estimated completion is 2022-11-30.
What interventions are being tested in trial NCT05509816?
The interventions under investigation include: Midazolam (DRUG), Imlunestrant (DRUG).
Who is sponsoring clinical trial NCT05509816?
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 NCT05509816's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 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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