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NCT05657613
Drug-Drug Interaction Study of Pacritinib and CYP450,Transporter Substrates, and CYP450 3A4 in Healthy Male Subjects
Phase 1 trial testing CYP450 Cocktail and Transporter Substrates with Pacritinib in Drug Interactions in 60 participants. Completed in 8 June 2023.
8 June 2023
Quick facts
| Lead sponsor | CTI BioPharma |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 3 January 2023 |
| Primary completion | 8 June 2023 |
| Estimated completion | 8 June 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- CYP450 Cocktail and Transporter Substrates with Pacritinib — full drug profile →
- Part 2 -Group A Bosentan 125 mg (CYP450 3A4 inducer) with Pacritinib — full drug profile →
- Part 2 Group B - Fluconazole (CYP450 3A4 inhibitor) with Pacritinib — full drug profile →
Conditions studied
- Drug Interactions — all drugs for Drug Interactions →
Sponsor
CTI BioPharma — full company profile →
Who can join
Adults 18 to 55, male only, with Drug Interactions. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase 1, open-label, fixed-sequence, 2-part DDI study. Subjects will participate in only 1 study part.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05657613
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Drug Interactions
Currently open trials in the same condition.
- NCT06865885 — LDL-C Optimization Using Inclisiran in Patients in Which Drug-Drug Interactions Limit LDL Lowering · Phase 4 · recruiting
- NCT06757140 — Opioid Drug Interaction Study · Phase 1, PHASE2 · recruiting
- NCT06401863 — Shared Decision for Drug Interactions in Oral Anticoagulation · NA · recruiting
- NCT06159699 — Telecommunication Technology-based Online Survey · recruiting
Other CTI BioPharma trials
Trials by the same sponsor.
- NCT05552183 — Study to Evaluate the Safety, Tolerability, and PK of Pacritinib · Phase 1 · completed
- NCT04404361 — PRE-VENT Study in Hospitalized Patients With Severe COVID-19 With or Without Cancer · Phase 2 · terminated
- NCT04884191 — Phase 2 Study: An Open-Label, Randomized, Phase 2 Dose-Finding Study of Pacritinib in Patients With Primary Myelofibrosi · Phase 2 · completed
- NCT02800889 — Dose-Escalation Study of Pixantrone Monotherapy in Pediatric Patients With Relapsed or Refractory Cancer · Phase 1 · withdrawn
- NCT01321541 — Comparison of Pixantrone + Rituximab With Gemcitabine + Rituximab in Patients With Aggressive B-cell Non-Hodgkin Lymphom · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05657613 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by CTI BioPharma
- Last refreshed: 17 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05657613.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing