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NCT00866190 · ClinicalTrials.gov registry record · Phase 1

Dose Escalation Study of SQ109 in Healthy Adult Volunteers

A Phase 1 study of TB Multi-drug Resistant, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
10
Enrollment target
1
Study location

NCT00866190 is a Phase 1 study of TB Multi-drug Resistant that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 10 participants. The trial reports 1 study location across 1 state.

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The verdict

NCT00866190, a Phase 1 study of TB Multi-drug Resistant, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
10 participants
Enrollment target
1
Study location

Study Summary

The purposes of this study are to determine: how safe it is to take SQ109 (an experimental tuberculosis treatment) once a day by mouth for up to 2 weeks in 2 different dosages; how well the body accepts it; how SQ109 enters and leaves the body and blood tissues over time; the amounts that can be detected in the blood; and how long it stays in the body. The study involves 30 volunteers: 24 will receive SQ109 and 6 will receive placebo (inactive substance). Qualified participants will be admitted to the study unit within 28 days from the screening and stay as inpatient for approximately 2 weeks. During this period they will receive study drug and complete all scheduled procedures including multiple blood draws. After discharge, there is a 14 day follow up period. Total study participation is about 56 days.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG SQ109

Study Locations (1)

Kansas

  • Quintiles Phase I Services - Overland Park

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2009-04
Est. Completion 2009-11
Phase Phase 1

What the Registry Record Tells You About NCT00866190

The ClinicalTrials.gov registry entry for NCT00866190 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with TB Multi-drug Resistant appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00866190 reports 1 study location spanning 1 distinct geographic area - top geographies include Kansas.

Frequently Asked Questions

What is clinical trial NCT00866190 about?

NCT00866190 is a clinical study titled "Dose Escalation Study of SQ109 in Healthy Adult Volunteers". The purposes of this study are to determine: how safe it is to take SQ109 (an experimental tuberculosis treatment) once a day by mouth for up to 2 weeks in 2 different dosages; how well the body accepts it; how SQ109 enters and leaves the body and blood tissues over time; the amounts that can be det...

What is the current status of trial NCT00866190?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2009-04. Estimated completion is 2009-11.

What conditions does trial NCT00866190 study?

This clinical trial studies the following conditions: TB Multi-drug Resistant.

What interventions are being tested in trial NCT00866190?

The interventions under investigation include: Placebo (DRUG), SQ109 (DRUG).

Who is sponsoring clinical trial NCT00866190?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00866190 being conducted?

This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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.