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NCT02334501 · ClinicalTrials.gov registry record · Phase 1

Open-label PK Study to Evaluate Lansoprazole and Neratinib in Healthy Subjects

A Phase 1 study, sponsored by Puma Biotechnology.

Completed
Registry status
Phase 1
Development phase
15
Enrollment target

NCT02334501 is a Phase 1 study that has completed, run by Puma Biotechnology. The registered enrollment target is 15 participants.

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The verdict

NCT02334501, a Phase 1 study, has completed, sponsored by Puma Biotechnology.

COMPLETED
Registry status
Phase 1
Development phase
15 participants
Enrollment target

Study Summary

This is an open label, 2-period, fixed-sequence study in 15 healthy adult subjects under fed conditions. To evaluate the effect of multiple doses of lansoprazole on the absorption and pharmacokinetics (PK) of a single dose of neratinib in healthy subjects.

Interventions

  • DRUG Neratinib
  • DRUG Lansoprazole

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2014-08
Est. Completion 2014-10
Phase Phase 1

Sponsor

Puma Biotechnology

28 total trials

What the Registry Record Tells You About NCT02334501

The ClinicalTrials.gov registry entry for NCT02334501 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Puma Biotechnology, which has 28 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Neratinib is the first listed.

NCT02334501 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02334501 about?

NCT02334501 is a clinical study titled "Open-label PK Study to Evaluate Lansoprazole and Neratinib in Healthy Subjects". This is an open label, 2-period, fixed-sequence study in 15 healthy adult subjects under fed conditions. To evaluate the effect of multiple doses of lansoprazole on the absorption and pharmacokinetics (PK) of a single dose of neratinib in healthy subjects.

What is the current status of trial NCT02334501?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2014-08. Estimated completion is 2014-10.

What interventions are being tested in trial NCT02334501?

The interventions under investigation include: Neratinib (DRUG), Lansoprazole (DRUG).

Who is sponsoring clinical trial NCT02334501?

This trial is sponsored by Puma Biotechnology, which has 28 total clinical trials registered on ClinicalTrials.gov.

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

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.