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NCT01209117 · ClinicalTrials.gov registry record · Phase 1

A Study to Assess the Relative Bioavailability of Tablet Formulations of GSK2248761 in Healthy Adult Subjects. SGN114435

A Phase 1 study, sponsored by ViiV Healthcare.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target

NCT01209117 is a Phase 1 study that has completed, run by ViiV Healthcare. The registered enrollment target is 24 participants.

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The verdict

NCT01209117, a Phase 1 study, has completed, sponsored by ViiV Healthcare.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target

Study Summary

This is a single-center, randomized, two part, open-label, crossover study in healthy adult subjects to assess the oral bioavailability of three GSK2248761 Wet Bead Milled (WBM) tablet formulations manufactured by three different processes relative to the GSK2248761 WBM capsule formulation (Part A) and the effect of a moderate-fat meal on the bioavailability of the selected WBM tablet formulation (Part B).

Interventions

  • DRUG GSK2248761 WBM Capsule
  • DRUG GSK2248761 WBM Tablet Formulation 1
  • DRUG GSK2248761 WBM Tablet Formulation 2
  • DRUG GSK2248761 WBM Tablet Formulation 3
  • DRUG GSK2248761 WBM Tablet

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2010-09
Est. Completion 2011-01
Phase Phase 1

Sponsor

ViiV Healthcare

182 total trials

What the Registry Record Tells You About NCT01209117

The ClinicalTrials.gov registry entry for NCT01209117 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ViiV Healthcare, which has 182 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which GSK2248761 WBM Capsule is the first listed.

NCT01209117 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01209117 about?

NCT01209117 is a clinical study titled "A Study to Assess the Relative Bioavailability of Tablet Formulations of GSK2248761 in Healthy Adult Subjects. SGN114435". This is a single-center, randomized, two part, open-label, crossover study in healthy adult subjects to assess the oral bioavailability of three GSK2248761 Wet Bead Milled (WBM) tablet formulations manufactured by three different processes relative to the GSK2248761 WBM capsule formulation (Part A) ...

What is the current status of trial NCT01209117?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2010-09. Estimated completion is 2011-01.

What interventions are being tested in trial NCT01209117?

The interventions under investigation include: GSK2248761 WBM Capsule (DRUG), GSK2248761 WBM Tablet Formulation 1 (DRUG), GSK2248761 WBM Tablet Formulation 2 (DRUG), GSK2248761 WBM Tablet Formulation 3 (DRUG), GSK2248761 WBM Tablet (DRUG).

Who is sponsoring clinical trial NCT01209117?

This trial is sponsored by ViiV Healthcare, which has 182 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.