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NCT04405323 · ClinicalTrials.gov registry record · Phase 1
Study That Evaluates the Effect of CYP3A4 Inhibition on Lu AG06466 in Healthy Men and Women
A Phase 1 study, sponsored by H. Lundbeck A/S.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT04405323: Completed Phase 1 study, sponsored by H. Lundbeck A/S.
NCT04405323 is a Phase 1 study that has completed, run by H. Lundbeck A/S. 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
NCT04405323, a Phase 1 study, has completed, sponsored by H. Lundbeck A/S.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
A study to learn how a drug (itraconazole) that is known to inhibit a certain enzym in the liver, impacts the body's ability to breakdown Lu AG06466 into breakdown products in healthy men and women. The main breakdown product is Lu AG06988.
Primary Outcome
Area under the Lu AG06466 plasma concentration-time curve from time zero to infinity
Interventions
- DRUG Itraconazole
- DRUG Lu AG06466
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2020-05-20 |
| Est. Completion | 2020-07-28 |
| Phase | Phase 1 |
What the finished NCT04405323 record still lists
NCT04405323 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 2 interventions - of which Itraconazole is the first listed.
NCT04405323 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04405323 about?
NCT04405323 is a clinical study titled "Study That Evaluates the Effect of CYP3A4 Inhibition on Lu AG06466 in Healthy Men and Women". A study to learn how a drug (itraconazole) that is known to inhibit a certain enzym in the liver, impacts the body's ability to breakdown Lu AG06466 into breakdown products in healthy men and women. The main breakdown product is Lu AG06988.
What is the current status of trial NCT04405323?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2020-05-20. Estimated completion is 2020-07-28.
What interventions are being tested in trial NCT04405323?
The interventions under investigation include: Itraconazole (DRUG), Lu AG06466 (DRUG).
Who is sponsoring clinical trial NCT04405323?
This trial is sponsored by H. Lundbeck A/S, which has 72 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04405323'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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