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NCT00990990 · ClinicalTrials.gov registry record · Phase 1

Safety, Tolerability, Pharmacokinetics And Measurement Of Whole Blood Activity (WBA) Of PNU-100480 After Multiple Oral Doses In Healthy Adult Volunteers

A Phase 1 study, sponsored by Sequella.

Completed
Registry status
Phase 1
Development phase
59
Enrollment target

NCT00990990 is a Phase 1 study that has completed, run by Sequella. The registered enrollment target is 59 participants.

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The verdict

NCT00990990, a Phase 1 study, has completed, sponsored by Sequella.

COMPLETED
Registry status
Phase 1
Development phase
59 participants
Enrollment target

Study Summary

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of multiple doses of PNU-100480 given for 14 or 28 days. Killing activity against the bacterium that causes tuberculosis (TB) will also be measured. The effect of adding an additional tuberculosis (TB) agent (given for 2 days) in addition to PNU-100480 will be evaluated. Linezolid open label to determine activity in whole blood assay (WBA).

Interventions

  • DRUG Placebo
  • DRUG PNU-100480

Trial Details

FieldValue
Enrollment Target 59 participants
Start Date 2009-10
Est. Completion 2010-05
Phase Phase 1

Sponsor

Sequella

3 total trials

What the Registry Record Tells You About NCT00990990

The ClinicalTrials.gov registry entry for NCT00990990 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sequella, which has 3 total studies on file at ClinicalTrials.gov.

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

NCT00990990 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00990990 about?

NCT00990990 is a clinical study titled "Safety, Tolerability, Pharmacokinetics And Measurement Of Whole Blood Activity (WBA) Of PNU-100480 After Multiple Oral Doses In Healthy Adult Volunteers". The purpose of this study is to assess the safety, tolerability and pharmacokinetics of multiple doses of PNU-100480 given for 14 or 28 days. Killing activity against the bacterium that causes tuberculosis (TB) will also be measured. The effect of adding an additional tuberculosis (TB) agent (given ...

What is the current status of trial NCT00990990?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 59 participants. The study started on 2009-10. Estimated completion is 2010-05.

What interventions are being tested in trial NCT00990990?

The interventions under investigation include: Placebo (DRUG), PNU-100480 (DRUG).

Who is sponsoring clinical trial NCT00990990?

This trial is sponsored by Sequella, which has 3 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.