Influence of Fedratinib on the Pharmacokinetics of the Transporter Probe Substrates Digoxin, Rosuvastatin, and Metformin

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.

Timeline

Start

2019-12-18

Primary completion

2020-02-19

Completion

2020-02-21

Publications

• Ogasawara K, Wood-Horrall RN, Thomas M, Thomas M, Liu L, Liu M, Xue Y, Surapaneni S, Carayannopoulos LN, Zhou S, Palmisano M, Krishna G. Impact of fedratinib on the pharmacokinetics of transporter probe substrates using a cocktail approach. Cancer Chemother Pharmacol. 2021 Dec;88(6):941-952. doi: 10.1007/s00280-021-04346-7. Epub 2021 Sep 3.

Drugs

Indications

No indication recorded.