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NCT01324323 · ClinicalTrials.gov registry record · Phase 1
Influence of Rifampin on the Pharmacokinetics of Romidepsin in Patients With Advanced Cancer
A Phase 1 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT01324323: Completed Phase 1 study, sponsored by Celgene.
NCT01324323 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01324323, a Phase 1 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effect and safety of multiple doses of rifampin on the pharmacokinetics of romidepsin after a single intravenous (IV) infusion.
Primary Outcome
AUC0-t: area under the plasma concentration time-curve from Time 0 to the time of the last quantifiable concentration (Ct), calculated by linear trapezoidal method when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing.
Interventions
- DRUG Rifampin
- DRUG Romidepsin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2011-04-01 |
| Est. Completion | 2012-03-01 |
| Phase | Phase 1 |
What the finished NCT01324323 record still lists
NCT01324323 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Rifampin is the first listed.
NCT01324323 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01324323 about?
NCT01324323 is a clinical study titled "Influence of Rifampin on the Pharmacokinetics of Romidepsin in Patients With Advanced Cancer". The purpose of this study is to evaluate the effect and safety of multiple doses of rifampin on the pharmacokinetics of romidepsin after a single intravenous (IV) infusion.
What is the current status of trial NCT01324323?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2011-04-01. Estimated completion is 2012-03-01.
What interventions are being tested in trial NCT01324323?
The interventions under investigation include: Rifampin (DRUG), Romidepsin (DRUG).
Who is sponsoring clinical trial NCT01324323?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01324323's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 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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