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NCT00975936 · ClinicalTrials.gov registry record · Phase 1

Phase 0 Microdose Study

A Phase 1 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 1
Development phase
12
Enrollment target

NCT00975936 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 12 participants.

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The verdict

NCT00975936, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 1
Development phase
12 participants
Enrollment target

Study Summary

This study is a methodology study to evaluate a microdose strategy for Drug-Drug Interaction (DDI) which will be useful in the evaluation of the backup compounds for GSK706769, as well as possibly other assets. The safety, tolerability and pharmacokinetics will be evaluated in healthy adult subjects. This will be an open-label fixed-sequence 2-period study in healthy male volunteers after oral administration of \[14C\]-GSK706769 alone and in the presence of Ketoconazole.

Interventions

  • DRUG Ketoconazole
  • DRUG [14C]-GSK706769

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2009-09-21
Est. Completion 2009-11-12
Phase Phase 1

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT00975936

The ClinicalTrials.gov registry entry for NCT00975936 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Ketoconazole is the first listed.

NCT00975936 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00975936 about?

NCT00975936 is a clinical study titled "Phase 0 Microdose Study". This study is a methodology study to evaluate a microdose strategy for Drug-Drug Interaction (DDI) which will be useful in the evaluation of the backup compounds for GSK706769, as well as possibly other assets. The safety, tolerability and pharmacokinetics will be evaluated in healthy adult subjects...

What is the current status of trial NCT00975936?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2009-09-21. Estimated completion is 2009-11-12.

What interventions are being tested in trial NCT00975936?

The interventions under investigation include: Ketoconazole (DRUG), [14C]-GSK706769 (DRUG).

Who is sponsoring clinical trial NCT00975936?

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

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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.