drugset / Trial / NCT03983239
Effect of Rifampin and Efavirenz on the Pharmacokinetics of Fedratinib in Healthy Adult Subjects
Phase 1
Completed
32 enrolled
Celgene Corporation
Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation · collab
Non-randomizedCrossoverOpen-labelTreatment
Summary
This is a 2-part study to evaluate the effect of multiple doses of rifampin or efavirenz on the PK, safety, and tolerability of single doses of fedratinib in healthy subjects. Each study part will consist of a nonrandomized, fixed-sequence, open-label design. The study parts can be run in any order or in parallel. Subjects may participate in one part only. For each part, subjects will participate as follows: * Screening * Treatment period (includes baseline) * Follow-up telephone call (4 days \[± 2 days\] after discharge) During the study, blood samples will be collected at prespecified times for PK. Subject safety will be monitored throughout the study.
Timeline
- Start
- 2019-06-21
- Primary completion
- 2019-11-02
- Completion
- 2019-11-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Efavirenz | Other / unclassified | 600 mg | — |
| Subject | Fedratinib | Small molecule | 500 mg | Oral |
| Subject | Rifampin | Small molecule | 600 mg | — |
Indications
No indication recorded.