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NCT04609696 · ClinicalTrials.gov registry record · Phase 1
Study of the Metabolism of Danicopan in Healthy Adults
A Phase 1 study, sponsored by Alexion Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT04609696: Completed Phase 1 study, sponsored by Alexion Pharmaceuticals.
NCT04609696 is a Phase 1 study that has completed, run by Alexion Pharmaceuticals. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04609696, a Phase 1 study, has completed, sponsored by Alexion Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This is a 2-part open-label, randomized, single-dose, 3-sequence, 3-period crossover, relative bioavailability, and food-effect study comparing different formulations of danicopan in healthy adult participants.
Primary Outcome
The relative bioavailability of the PIC 1 formulation versus the tablet formulation will be measured by the ratio of select pharmacokinetic (PK) parameters: maximum observed plasma concentration (Cmax), area under the concentration-time curve from time of administration to the last measurable concentration (AUC0-t), and area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf).
Interventions
- DRUG Danicopan: Powder-In-Capsule 1
- DRUG Danicopan: Powder-In-Capsule 2
- DRUG Danicopan: Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2020-10-20 |
| Est. Completion | 2020-12-07 |
| Phase | Phase 1 |
What the finished NCT04609696 record still lists
NCT04609696 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 3 interventions - of which Danicopan: Powder-In-Capsule 1 is the first listed.
NCT04609696 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04609696 about?
NCT04609696 is a clinical study titled "Study of the Metabolism of Danicopan in Healthy Adults". This is a 2-part open-label, randomized, single-dose, 3-sequence, 3-period crossover, relative bioavailability, and food-effect study comparing different formulations of danicopan in healthy adult participants.
What is the current status of trial NCT04609696?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2020-10-20. Estimated completion is 2020-12-07.
What interventions are being tested in trial NCT04609696?
The interventions under investigation include: Danicopan: Powder-In-Capsule 1 (DRUG), Danicopan: Powder-In-Capsule 2 (DRUG), Danicopan: Tablet (DRUG).
Who is sponsoring clinical trial NCT04609696?
This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04609696's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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