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NCT02118909 · ClinicalTrials.gov registry record · Phase 1
Evaluate the Effects of Itraconazole and Ciprofloxacin on Single-Dose PK of Pracinostat in Healthy Nonsmoking Subjects
A Phase 1 study, sponsored by Helsinn Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT02118909: Completed Phase 1 study, sponsored by Helsinn Healthcare.
NCT02118909 is a Phase 1 study that has completed, run by Helsinn Healthcare. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02118909, a Phase 1 study, has completed, sponsored by Helsinn Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
This study is designed as a 2-part, open-label study to assess the effect of pracinostat with itraconazole (part 1) and pracinostat with ciprofloxacin (part 2) on the bioavailability of pracinostat. Secondarily to evaluate the safety and tolerability of pracinostat administered with itraconazole or ciprofloxacin.
Primary Outcome
Plasma PK parameter Cmax to describe bioavailability of pracinostat
Interventions
- DRUG Itraconazole
- DRUG Ciprofloxacin
- DRUG Pracinostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2014-05 |
| Est. Completion | 2014-08 |
| Phase | Phase 1 |
What the finished NCT02118909 record still lists
NCT02118909 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 3 interventions - of which Itraconazole is the first listed.
NCT02118909 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02118909 about?
NCT02118909 is a clinical study titled "Evaluate the Effects of Itraconazole and Ciprofloxacin on Single-Dose PK of Pracinostat in Healthy Nonsmoking Subjects". This study is designed as a 2-part, open-label study to assess the effect of pracinostat with itraconazole (part 1) and pracinostat with ciprofloxacin (part 2) on the bioavailability of pracinostat. Secondarily to evaluate the safety and tolerability of pracinostat administered with itraconazole or ...
What is the current status of trial NCT02118909?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2014-05. Estimated completion is 2014-08.
What interventions are being tested in trial NCT02118909?
The interventions under investigation include: Itraconazole (DRUG), Ciprofloxacin (DRUG), Pracinostat (DRUG).
Who is sponsoring clinical trial NCT02118909?
This trial is sponsored by Helsinn Healthcare, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02118909's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 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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