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NCT00659191 · ClinicalTrials.gov registry record · Phase 1

A Healthy Volunteer And Patient Study To Assess The Safety, Tolerability And Pharmacokinetics Of GSK1265744

A Phase 1 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 1
Development phase
58
Enrollment target

NCT00659191 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 58 participants.

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The verdict

NCT00659191, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 1
Development phase
58 participants
Enrollment target

Study Summary

This study is a Phase I single and repeat dose escalation study of GSK1265744 in healthy subjects and a single repeat dose cohort in HIV-1 infected subjects. The study is planned to consist of three parts. Part A will enroll two cohorts with a total of 18 subjects in a single dose escalation to evaluate safety, tolerability and PK. Part B plans to enroll three cohorts of 10 subjects to evaluate repeat doses of GSK126744 on safety, tolerability and PK. Part A and B will enroll healthy volunteers. Part C will enroll HIV-1 patients in a single cohort of 10 subjects. This cohort will evaluate the effects of repeat dose on safety, tolerability, PK and efficacy.

Interventions

  • DRUG GSK1265744

Trial Details

FieldValue
Enrollment Target 58 participants
Start Date 2008-02
Est. Completion 2008-11
Phase Phase 1

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT00659191

The ClinicalTrials.gov registry entry for NCT00659191 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 58 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 1 intervention - of which GSK1265744 is the first listed.

NCT00659191 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00659191 about?

NCT00659191 is a clinical study titled "A Healthy Volunteer And Patient Study To Assess The Safety, Tolerability And Pharmacokinetics Of GSK1265744". This study is a Phase I single and repeat dose escalation study of GSK1265744 in healthy subjects and a single repeat dose cohort in HIV-1 infected subjects. The study is planned to consist of three parts. Part A will enroll two cohorts with a total of 18 subjects in a single dose escalation to eval...

What is the current status of trial NCT00659191?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 58 participants. The study started on 2008-02. Estimated completion is 2008-11.

What interventions are being tested in trial NCT00659191?

The interventions under investigation include: GSK1265744 (DRUG).

Who is sponsoring clinical trial NCT00659191?

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.