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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.

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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

FieldValue
Enrollment Target 20 participants
Start Date 2019-02-26
Est. Completion 2019-04-10
Phase Phase 1

Sponsor

Shire

245 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.