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NCT01162486 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics, Safety and Tolerability of Escalating Rifapentine Doses in Healthy Volunteers
A Phase 1 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
NCT01162486: Completed Phase 1 study, sponsored by Johns Hopkins University.
NCT01162486 is a Phase 1 study that has completed, run by Johns Hopkins University. The registered enrollment target is 37 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01162486, a Phase 1 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
Study Summary
The aim of this study is to evaluate (1) the safety and tolerability of escalating doses of rifapentine (RPT) administered daily by oral; (2) the effect of increasing doses of RPT on cytochrome P450 isoform 3A (CYP3A) enzyme metabolizing activity, using single-dose midazolam (MDZ); and (3) the effect of increasing doses of RPT on autoinduction of RPT metabolism.
Interventions
- DRUG Rifampin & midazolam
- DRUG rifapentine & midazolam
- DRUG rifapentine and midazolam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2010-04 |
| Est. Completion | 2011-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01162486
The ClinicalTrials.gov registry entry for NCT01162486 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Rifampin & midazolam is the first listed.
NCT01162486 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01162486 about?
NCT01162486 is a clinical study titled "Pharmacokinetics, Safety and Tolerability of Escalating Rifapentine Doses in Healthy Volunteers". The aim of this study is to evaluate (1) the safety and tolerability of escalating doses of rifapentine (RPT) administered daily by oral; (2) the effect of increasing doses of RPT on cytochrome P450 isoform 3A (CYP3A) enzyme metabolizing activity, using single-dose midazolam (MDZ); and (3) the effec...
What is the current status of trial NCT01162486?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2010-04. Estimated completion is 2011-03.
What interventions are being tested in trial NCT01162486?
The interventions under investigation include: Rifampin & midazolam (DRUG), rifapentine & midazolam (DRUG), rifapentine and midazolam (DRUG).
Who is sponsoring clinical trial NCT01162486?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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