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NCT00814060 · ClinicalTrials.gov registry record · Phase 1

Study Evaluating TwoTablet Formulations of Neratinib (HKI-272)

A Phase 1 study, sponsored by Puma Biotechnology.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target

NCT00814060: Completed Phase 1 study, sponsored by Puma Biotechnology.

NCT00814060 is a Phase 1 study that has completed, run by Puma Biotechnology. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00814060, a Phase 1 study, has completed, sponsored by Puma Biotechnology.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target

Study Summary

This study will examine the bioavailability (the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action) of two tablet formulations of Neratinib (HKI-272) compared to the capsule formulation.

Interventions

  • DRUG neratinib

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2009-01
Est. Completion 2009-03
Phase Phase 1
Puma Biotechnology

28 total trials

What the finished NCT00814060 record still lists

NCT00814060 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).

The record links to 0 conditions, and to 1 intervention - of which neratinib is the first listed.

NCT00814060 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00814060 about?

NCT00814060 is a clinical study titled "Study Evaluating TwoTablet Formulations of Neratinib (HKI-272)". This study will examine the bioavailability (the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action) of two tablet formulations of Neratinib (HKI-272) compared to the capsule formulation.

What is the current status of trial NCT00814060?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2009-01. Estimated completion is 2009-03.

What interventions are being tested in trial NCT00814060?

The interventions under investigation include: neratinib (DRUG).

Who is sponsoring clinical trial NCT00814060?

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

How this trial's enrollment target compares

Where NCT00814060's enrollment target sits among peer trials

24 1520th of 2000 higher than 405 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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Source: ClinicalTrials.gov NCT00814060, the US trial registry maintained by the National Library of Medicine. NCT00814060 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.