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NCT01231568 · ClinicalTrials.gov registry record · Phase 1

An Open Label Study to Examine the Effects of a High-Fat Meal and Particle Size on the Pharmacokinetics of Orally Administered GSK2118436 in Subjects With BRAF Mutation Positive Tumor

A Phase 1 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 1
Development phase
28
Enrollment target

NCT01231568: Completed Phase 1 study, sponsored by GlaxoSmithKline.

NCT01231568 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01231568, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 1
Development phase
28 participants
Enrollment target

Study Summary

The study is designed to evaluate the effects of a high fat meal on the pharmacokinetics of 150 mg of GSK2118436, as well as the effects of particle size on the relative bioavailability of GSK2118436.

Interventions

  • DRUG Regimen A
  • DRUG Regimen B
  • DRUG Regimen C
  • DRUG Regimen D

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2010-10-21
Est. Completion 2011-05-13
Phase Phase 1
GlaxoSmithKline

1,345 total trials

What the finished NCT01231568 record still lists

NCT01231568 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).

The record links to 0 conditions, and to 4 interventions - of which Regimen A is the first listed.

NCT01231568 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01231568 about?

NCT01231568 is a clinical study titled "An Open Label Study to Examine the Effects of a High-Fat Meal and Particle Size on the Pharmacokinetics of Orally Administered GSK2118436 in Subjects With BRAF Mutation Positive Tumor". The study is designed to evaluate the effects of a high fat meal on the pharmacokinetics of 150 mg of GSK2118436, as well as the effects of particle size on the relative bioavailability of GSK2118436.

What is the current status of trial NCT01231568?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2010-10-21. Estimated completion is 2011-05-13.

What interventions are being tested in trial NCT01231568?

The interventions under investigation include: Regimen A (DRUG), Regimen B (DRUG), Regimen C (DRUG), Regimen D (DRUG).

Who is sponsoring clinical trial NCT01231568?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01231568's enrollment target sits among peer trials

28 1447th of 2000 higher than 538 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 NCT01231568, the US trial registry maintained by the National Library of Medicine. NCT01231568 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.