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NCT03768388 · ClinicalTrials.gov registry record · Phase 1
Levoketoconazole Food Effect Study in Healthy Subjects
A Phase 1 study, sponsored by Cortendo AB.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT03768388: Completed Phase 1 study, sponsored by Cortendo AB.
NCT03768388 is a Phase 1 study that has completed, run by Cortendo AB. 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
NCT03768388, a Phase 1 study, has completed, sponsored by Cortendo AB.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
This is a phase I, randomized, open-label, single-dose, two-period, two-sequence crossover study in healthy male and female subjects to evaluate the effect of food on the PK of levoketoconazole.
Primary Outcome
Maximum observed plasma concentration (Cmax) of levoketoconazole for fed vs. fasted condition
Interventions
- DRUG levoketoconazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2018-11-30 |
| Est. Completion | 2018-12-24 |
| Phase | Phase 1 |
What the finished NCT03768388 record still lists
NCT03768388 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 1 intervention - of which levoketoconazole is the first listed.
NCT03768388 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03768388 about?
NCT03768388 is a clinical study titled "Levoketoconazole Food Effect Study in Healthy Subjects". This is a phase I, randomized, open-label, single-dose, two-period, two-sequence crossover study in healthy male and female subjects to evaluate the effect of food on the PK of levoketoconazole.
What is the current status of trial NCT03768388?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2018-11-30. Estimated completion is 2018-12-24.
What interventions are being tested in trial NCT03768388?
The interventions under investigation include: levoketoconazole (DRUG).
Who is sponsoring clinical trial NCT03768388?
This trial is sponsored by Cortendo AB, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03768388'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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