Effect of Rifampin and Efavirenz on the Pharmacokinetics of Fedratinib in Healthy Adult Subjects
Status:
Completed
Trial end date:
2019-11-06
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Celgene
Collaborator:
Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation