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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: Completed Phase 1 study, sponsored by Shire.
NCT03866434 is a Phase 1 study that has completed, run by Shire. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Cmax of Anagrelide (SPD422) on Day 1 and Day 8 was reported. For PK outcome measures the reporting groups were split based on administration of Anagrelide alone (Day 1) and Anagrelide in combination with Omeprazole (Day 8) to provide statistical comparison in this single arm study.
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 |
What the finished NCT03866434 record still lists
NCT03866434 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Omeprazole is the first listed.
NCT03866434 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03866434's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 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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