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NCT01674218 · ClinicalTrials.gov registry record · Phase 1

Effect of PA-824 and of PA-824 Plus Moxifloxacin on the QTc Interval in Healthy Volunteers

A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
74
Enrollment target

NCT01674218: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT01674218 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 74 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01674218, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
74 participants
Enrollment target

Study Summary

This is a Phase I, single-center, double-blinded, randomized, placebo-controlled, five-period cross-over clinical study of PA-824 to evaluate the effect of PA-824 and of PA-824 plus moxifloxacin on cardiac repolarization (QT/QTc interval duration) in a total of 75 healthy male and female participants, aged 18 to 45 years. Moxifloxacin will be used as an active control. Participants will be blinded to the treatments they will receive. The study consists of a screening period up to 26 days; enrollment, 1 day; five in-patient treatment periods consisting of an admission day (except in the first treatment period, when the pre-dose day is the baseline), dosing day and two post-dosing days; an out-patient period of at least three days and not more than 10 days between treatment periods; and a final visit 7 - 14 days after discharge from the last treatment period.

Interventions

  • OTHER Placebo
  • DRUG Moxifloxacin
  • DRUG PA-824

Trial Details

FieldValue
Enrollment Target 74 participants
Start Date 2012-09
Est. Completion 2012-12
Phase Phase 1

What the finished NCT01674218 record still lists

NCT01674218 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT01674218 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01674218 about?

NCT01674218 is a clinical study titled "Effect of PA-824 and of PA-824 Plus Moxifloxacin on the QTc Interval in Healthy Volunteers". This is a Phase I, single-center, double-blinded, randomized, placebo-controlled, five-period cross-over clinical study of PA-824 to evaluate the effect of PA-824 and of PA-824 plus moxifloxacin on cardiac repolarization (QT/QTc interval duration) in a total of 75 healthy male and female participant...

What is the current status of trial NCT01674218?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2012-09. Estimated completion is 2012-12.

What interventions are being tested in trial NCT01674218?

The interventions under investigation include: Placebo (OTHER), Moxifloxacin (DRUG), PA-824 (DRUG).

Who is sponsoring clinical trial NCT01674218?

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

How this trial's enrollment target compares

Where NCT01674218's enrollment target sits among peer trials

74 725th of 2000 higher than 1,269 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01674218, the US trial registry maintained by the National Library of Medicine. NCT01674218 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.