NCT07226635

Pharmacokinetic Interaction Trial of Clofutriben With Midazolam and Prednisolone

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Sparrow Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Drug: 2 single oral doses of midazolam, 2 single oral doses of prednisolone , and clofutriben once daily for 16 days.

Detailed description

Approximately 16 healthy male and female participants will be enrolled at a single center in the US. Each participant will receive 2 single oral doses of midazolam , 2 single oral doses of prednisolone, and clofutriben once daily for 16 days. On each day that midazolam is administered, blood samples for midazolam analysis in plasma will be collected for 24 hours. On each day that prednisolone is administered, blood samples for prednisolone, prednisone, and 6β-hydroxyprednisolone analyses in plasma will be collected for 24 hours. Blood samples for clofutriben and metabolite (AS2570469) analyses in plasma will be collected for 24 hours after the first dose and during 2 intervals at steady state. Blood samples for cortisol and cortisone analyses will be collected for 24 hours after administration of prednisolone, clofutriben, and both trial interventions together, and prior to dosing of either trial intervention. Urine will be collected for analysis of clofutriben, prednisolone, and metabolites. Feces will be collected for analysis of clofutriben and metabolites. Safety and tolerability will be assessed.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	midazolam	Drug: 2 single oral doses of midazolam ,
DRUG	clofutriben once daily for 16 days	clofutriben once daily for 16 days
DRUG	2 single oral doses of prednisolone	2 single oral doses of prednisolone

Timeline

• Start date: 2025-10-03
• Primary completion: 2025-12-16
• Completion: 2025-12-16
• First posted: 2025-11-10
• Last updated: 2025-12-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study