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NCT03103646 · ClinicalTrials.gov registry record · Phase 1
Study Evaluating the Effect of Multiple Doses of Itraconazole on the Drug Lu AF35700 in Healthy Young Men and Women
A Phase 1 study, sponsored by H. Lundbeck A/S.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT03103646: Completed Phase 1 study, sponsored by H. Lundbeck A/S.
NCT03103646 is a Phase 1 study that has completed, run by H. Lundbeck A/S. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03103646, a Phase 1 study, has completed, sponsored by H. Lundbeck A/S.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
This study will investigate the effect of multiple doses of the strong P450 enzyme inhibitor itraconazole on the pharmacokinetics of Lu AF35700 in healthy subjects.
Primary Outcome
Area under the Lu AF35700 plasma concentration-time curve (with and without itraconazole) for CYP2D6 EMs
Interventions
- DRUG Lu AF35700
- DRUG Itraconazole (200 mg)
- DRUG Itraconazole (300 mg)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2017-03-28 |
| Est. Completion | 2019-07-19 |
| Phase | Phase 1 |
What the finished NCT03103646 record still lists
NCT03103646 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 3 interventions - of which Lu AF35700 is the first listed.
NCT03103646 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03103646 about?
NCT03103646 is a clinical study titled "Study Evaluating the Effect of Multiple Doses of Itraconazole on the Drug Lu AF35700 in Healthy Young Men and Women". This study will investigate the effect of multiple doses of the strong P450 enzyme inhibitor itraconazole on the pharmacokinetics of Lu AF35700 in healthy subjects.
What is the current status of trial NCT03103646?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2017-03-28. Estimated completion is 2019-07-19.
What interventions are being tested in trial NCT03103646?
The interventions under investigation include: Lu AF35700 (DRUG), Itraconazole (200 mg) (DRUG), Itraconazole (300 mg) (DRUG).
Who is sponsoring clinical trial NCT03103646?
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 NCT03103646's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 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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