NCT03983239

Effect of Rifampin and Efavirenz on the Pharmacokinetics of Fedratinib in Healthy Adult Subjects

A Phase 1, Open-label, 2-part Study to Evaluate the Effect of Rifampin and Efavirenz on the Pharmacokinetics of Fedratinib in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Fedratinib	Fedratinib
DRUG	Rifampin	Rifampin
DRUG	Efavirenz	Efavirenz

Timeline

• Start date: 2019-06-21
• Primary completion: 2019-11-02
• Completion: 2019-11-06
• First posted: 2019-06-12
• Last updated: 2020-08-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study