Influence of Fedratinib on the Pharmacokinetics of the Transporter Probe Substrates Digoxin, Rosuvastatin, and Metformin
Status:
Completed
Trial end date:
2020-02-21
Target enrollment:
Participant gender:
Summary
This is a nonrandomized, fixed-sequence, open-label study to evaluate the effect of a single
dose of fedratinib on the PK, safety, and tolerability of single doses of digoxin,
rosuvastatin, and metformin in healthy subjects. The subjects will participate as follows:
- Screening phase
- Treatment phase (includes baseline)
- Follow-up telephone call Subjects will be screened for eligibility during the screening
phase. Subjects who meet all inclusion criteria and none of the exclusion criteria will
return to the clinical site on Day -1 for protocol-specified assessments, and will be
domiciled at the clinical site from Day -1 through the morning of Day 22.
During the study, blood samples will be collected at prespecified times for PK and PD. Urine
samples will be collected at prespecified times for urinary PK evaluation of metformin.
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