NCT04231435

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

A Phase 1, Open-label Study to Evaluate the Influence of Fedratinib on the Pharmacokinetics of Transporter Probe Substrates (Digoxin, Rosuvastatin, and Metformin) in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Fedratinib	Oral
DRUG	Digoxin	Oral
DRUG	Rosuvastatin	Oral
DRUG	Metformin	Oral

Timeline

• Start date: 2019-12-18
• Primary completion: 2020-02-19
• Completion: 2020-02-21
• First posted: 2020-01-18
• Last updated: 2020-05-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study