Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00498745 · ClinicalTrials.gov registry record · Phase 1

Study Comparing 2 New Formulations of HKI-272 in Healthy Adult Subjects

A Phase 1 study, sponsored by Puma Biotechnology.

Completed
Registry status
Phase 1
Development phase
36
Enrollment target

NCT00498745: Completed Phase 1 study, sponsored by Puma Biotechnology.

NCT00498745 is a Phase 1 study that has completed, run by Puma Biotechnology. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00498745, a Phase 1 study, has completed, sponsored by Puma Biotechnology.

COMPLETED
Registry status
Phase 1
Development phase
36 participants
Enrollment target

Study Summary

To evaluate the comparative bioavailability of 2 new tablet formulations of HKI-272 with a reference capsule and an oral solution in healthy subjects.

Interventions

  • DRUG neratinib

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2007-07
Est. Completion 2007-09
Phase Phase 1
Puma Biotechnology

28 total trials

What the finished NCT00498745 record still lists

NCT00498745 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).

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

NCT00498745 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00498745 about?

NCT00498745 is a clinical study titled "Study Comparing 2 New Formulations of HKI-272 in Healthy Adult Subjects". To evaluate the comparative bioavailability of 2 new tablet formulations of HKI-272 with a reference capsule and an oral solution in healthy subjects.

What is the current status of trial NCT00498745?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2007-07. Estimated completion is 2007-09.

What interventions are being tested in trial NCT00498745?

The interventions under investigation include: neratinib (DRUG).

Who is sponsoring clinical trial NCT00498745?

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 NCT00498745's enrollment target sits among peer trials

36 1210th of 2000 higher than 743 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT00929006 · 36 participants · Early Phase 1

    Acute Progesterone Suppression of Wake vs. Sleep Luteinizing Hormone Pulse Frequency in Pubertal Girls With and Without Hyperandrogenism

  • NCT01891318 · 36 participants · Phase 1

    Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study

  • NCT02291848 · 36 participants · Phase 1

    Tumor-Associated Antigen-Specific Cytotoxic T-Lymphocytes for Multiple Myeloma

  • NCT02366819 · 36 participants · Phase 4

    Genetic Analysis-Guided Irinotecan Hydrochloride Dosing of mFOLFIRINOX in Treating Patients With Locally Advanced Gastroesophageal or Stomach Cancer

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT00498745, the US trial registry maintained by the National Library of Medicine. NCT00498745 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.