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NCT03866434 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Effect of Omeprazole on the Pharmacokinetics of SPD422 (Anagrelide Hydrochloride) in Healthy Adult Participants
A Phase 1 study, sponsored by Shire.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT03866434 is a Phase 1 study that has completed, run by Shire. The registered enrollment target is 20 participants.
The verdict
NCT03866434, a Phase 1 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
This Phase 1, open-label, single-sequence, non-randomized, multiple-dose, crossover pharmacokinetic study is a single site study in the United States and will be conducted to assess the effect of a CYP1A2 inducer (omeprazole 40 mg once daily \[QD\]) on the pharmacokinetics of anagrelide (1 mg) when administered concurrently in healthy participants.
Interventions
- DRUG Omeprazole
- DRUG SPD422
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-02-26 |
| Est. Completion | 2019-04-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03866434
The ClinicalTrials.gov registry entry for NCT03866434 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Omeprazole is the first listed.
NCT03866434 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03866434 about?
NCT03866434 is a clinical study titled "Study to Evaluate the Effect of Omeprazole on the Pharmacokinetics of SPD422 (Anagrelide Hydrochloride) in Healthy Adult Participants". This Phase 1, open-label, single-sequence, non-randomized, multiple-dose, crossover pharmacokinetic study is a single site study in the United States and will be conducted to assess the effect of a CYP1A2 inducer (omeprazole 40 mg once daily \[QD\]) on the pharmacokinetics of anagrelide (1 mg) when ...
What is the current status of trial NCT03866434?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2019-02-26. Estimated completion is 2019-04-10.
What interventions are being tested in trial NCT03866434?
The interventions under investigation include: Omeprazole (DRUG), SPD422 (DRUG).
Who is sponsoring clinical trial NCT03866434?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
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