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NCT01002378 · ClinicalTrials.gov registry record · Phase 1

The Effect of Food (High Fat and Low Fat Breakfast) on the Pharmacokinetics of Regorafenib

A Phase 1 study, sponsored by Bayer.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target

NCT01002378: Completed Phase 1 study, sponsored by Bayer.

NCT01002378 is a Phase 1 study that has completed, run by Bayer. 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

NCT01002378, a Phase 1 study, has completed, sponsored by Bayer.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target

Study Summary

An open label, three way crossover study to determine the effect of a high fat breakfast or a low fat breakfast on the pharmacokinetics of a single dose of regorafenib.

Interventions

  • DRUG Regorafenib (Stivarga, BAY73-4506)

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2009-10
Est. Completion 2010-02
Phase Phase 1
Bayer

591 total trials

What the finished NCT01002378 record still lists

NCT01002378 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 Regorafenib (Stivarga, BAY73-4506) is the first listed.

NCT01002378 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01002378 about?

NCT01002378 is a clinical study titled "The Effect of Food (High Fat and Low Fat Breakfast) on the Pharmacokinetics of Regorafenib". An open label, three way crossover study to determine the effect of a high fat breakfast or a low fat breakfast on the pharmacokinetics of a single dose of regorafenib.

What is the current status of trial NCT01002378?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2009-10. Estimated completion is 2010-02.

What interventions are being tested in trial NCT01002378?

The interventions under investigation include: Regorafenib (Stivarga, BAY73-4506) (DRUG).

Who is sponsoring clinical trial NCT01002378?

This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01002378'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 NCT01002378, the US trial registry maintained by the National Library of Medicine. NCT01002378 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.