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NCT05657613 · ClinicalTrials.gov registry record · Phase 1
Drug-Drug Interaction Study of Pacritinib and CYP450,Transporter Substrates, and CYP450 3A4 in Healthy Male Subjects
A Phase 1 study, sponsored by CTI BioPharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT05657613: Completed Phase 1 study, sponsored by CTI BioPharma.
NCT05657613 is a Phase 1 study that has completed, run by CTI BioPharma. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05657613, a Phase 1 study, has completed, sponsored by CTI BioPharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
This is a Phase 1, open-label, fixed-sequence, 2-part DDI study. Subjects will participate in only 1 study part.
Primary Outcome
Change in the systemic exposure of digoxin, midazolam omeprazole, rosuvastatin, caffeine and metformin when co-adminstered with pacritinib
Interventions
- DRUG CYP450 Cocktail and Transporter Substrates with Pacritinib
- DRUG Part 2 -Group A Bosentan 125 mg (CYP450 3A4 inducer) with Pacritinib
- DRUG Part 2 Group B - Fluconazole (CYP450 3A4 inhibitor) with Pacritinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-01-03 |
| Est. Completion | 2023-06-08 |
| Phase | Phase 1 |
What the finished NCT05657613 record still lists
NCT05657613 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which CYP450 Cocktail and Transporter Substrates with Pacritinib is the first listed.
NCT05657613 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05657613 about?
NCT05657613 is a clinical study titled "Drug-Drug Interaction Study of Pacritinib and CYP450,Transporter Substrates, and CYP450 3A4 in Healthy Male Subjects". This is a Phase 1, open-label, fixed-sequence, 2-part DDI study. Subjects will participate in only 1 study part.
What is the current status of trial NCT05657613?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2023-01-03. Estimated completion is 2023-06-08.
What interventions are being tested in trial NCT05657613?
The interventions under investigation include: CYP450 Cocktail and Transporter Substrates with Pacritinib (DRUG), Part 2 -Group A Bosentan 125 mg (CYP450 3A4 inducer) with Pacritinib (DRUG), Part 2 Group B - Fluconazole (CYP450 3A4 inhibitor) with Pacritinib (DRUG).
Who is sponsoring clinical trial NCT05657613?
This trial is sponsored by CTI BioPharma, which has 28 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05657613's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 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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