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NCT00164463 · ClinicalTrials.gov registry record · Phase 2
TBTC Study 27/28 PK: Moxifloxacin Pharmacokinetics During TB Treatment
A Phase 2 study, sponsored by Centers for Disease Control and Prevention.
- Completed
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
NCT00164463: Completed Phase 2 study, sponsored by Centers for Disease Control and Prevention.
NCT00164463 is a Phase 2 study that has completed, run by Centers for Disease Control and Prevention. The registered enrollment target is 72 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00164463, a Phase 2 study, has completed, sponsored by Centers for Disease Control and Prevention.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
Study Summary
This substudy of TBTC Studies 27 and 28 compares 1) the pharmacokinetics of moxifloxacin alone versus moxifloxacin administered with rifampin in healthy volunteers and 2) the pharmacokinetics of moxifloxacin among patients with tuberculosis being treated with multidrug therapy (isoniazid or ethambutol, rifampin, and pyrazinamide) to those of healthy volunteers receiving moxifloxacin plus rifampin. It also evaluates the association between polymorphisms of MDR1 genotype (P-glycoprotein) and rifampin pharmacokinetic parameters, the effect of polymorphisms of MDR1 genotype and/or rifampin pharmacokinetics on isoniazid pharmacokinetic parameters adjusted for N-acetyltransferase genotype (NAT2), and determines by multivariate regression analyses the associations between moxifloxacin or rifampin pharmacokinetic parameters and markers of tuberculosis disease severity including the covariates of two-month culture positivity, cavitary lung disease, Body Mass Index, weight, duration of study treatment prior to PK, co-morbidities and C-reactive protein. Healthy volunteers and TB patients receive frequent scheduled blood draws during a 24 hour period after ingesting a dose of TB drugs.
Interventions
- DRUG Moxifloxacin
- DRUG Isoniazid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2004-07 |
| Est. Completion | 2007-08 |
| Phase | Phase 2 |
What the finished NCT00164463 record still lists
NCT00164463 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% lower).
The record links to 0 conditions, and to 2 interventions - of which Moxifloxacin is the first listed.
NCT00164463 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00164463 about?
NCT00164463 is a clinical study titled "TBTC Study 27/28 PK: Moxifloxacin Pharmacokinetics During TB Treatment". This substudy of TBTC Studies 27 and 28 compares 1) the pharmacokinetics of moxifloxacin alone versus moxifloxacin administered with rifampin in healthy volunteers and 2) the pharmacokinetics of moxifloxacin among patients with tuberculosis being treated with multidrug therapy (isoniazid or ethambut...
What is the current status of trial NCT00164463?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2004-07. Estimated completion is 2007-08.
What interventions are being tested in trial NCT00164463?
The interventions under investigation include: Moxifloxacin (DRUG), Isoniazid (DRUG).
Who is sponsoring clinical trial NCT00164463?
This trial is sponsored by Centers for Disease Control and Prevention, which has 139 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00164463's enrollment target sits among peer trials
72 925th of 2000 higher than 1,065 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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