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Drug-Drug Interaction Study of Multiple Doses of Pacritinib and CYP450 And, Transporter Substrates, and CYP450 3A4 Inducers and Inhibitors

ClinicalTrials.gov · COMPLETED, 2023

60 participants

Abstract

This is a Phase 1, open-label, fixed-sequence, 2-part DDI study. Subjects will participate in only 1 study part.

Conditions: Drug Interactions.

Primary outcome: Change in area under curve (AUC) of individual substrates between cocktail alone and cocktail combined with pacritinib administration; Change in maximum plasma concentration (Cmax) of individual substrates between cocktail alone and cocktail combined with pacritinib administration; Change in area under curve (AUC) of pacritinib alone and pacritinib + bosentan administration; Change in Cmax of pacritinib alone and pacritinib + bosentan administration; Change in AUC of pacritinib alone and pacritinib + fluconazole administration; Change in Cmax of pacritinib alone and pacritinib + fluconazole administration.

Enrollment: 60 participants.

How strong is the evidence?

Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 60 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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