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NCT04526197 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Study of ALXN1840 on the Metabolism of a CYP2C9 Substrate in Healthy Participants.
A Phase 1 study, sponsored by Alexion Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT04526197 is a Phase 1 study that has completed, run by Alexion Pharmaceuticals. The registered enrollment target is 36 participants.
The verdict
NCT04526197, a Phase 1 study, has completed, sponsored by Alexion Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
This was a Phase 1, randomized, 2-period, 2-sequence, cross-over study designed to determine the effect of ALXN1840 on the metabolism of celecoxib, a sensitive cytochrome P450 2C9 (CYP2C9) substrate, in healthy male and female participants. The safety and tolerability of ALXN1840 were determined along with ALXN1840 pharmacokinetics (PK) in plasma as measured via total molybdenum with the coadministration of celecoxib.
Interventions
- DRUG Celecoxib
- DRUG ALXN1840
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2020-07-07 |
| Est. Completion | 2020-11-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04526197
The ClinicalTrials.gov registry entry for NCT04526197 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alexion Pharmaceuticals, which has 162 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Celecoxib is the first listed.
NCT04526197 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04526197 about?
NCT04526197 is a clinical study titled "Phase 1 Study of ALXN1840 on the Metabolism of a CYP2C9 Substrate in Healthy Participants.". This was a Phase 1, randomized, 2-period, 2-sequence, cross-over study designed to determine the effect of ALXN1840 on the metabolism of celecoxib, a sensitive cytochrome P450 2C9 (CYP2C9) substrate, in healthy male and female participants. The safety and tolerability of ALXN1840 were determined alo...
What is the current status of trial NCT04526197?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2020-07-07. Estimated completion is 2020-11-03.
What interventions are being tested in trial NCT04526197?
The interventions under investigation include: Celecoxib (DRUG), ALXN1840 (DRUG).
Who is sponsoring clinical trial NCT04526197?
This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.
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