NCT07227922

Clofutriben Pharmacokinetics in Patients With Impaired Renal Function

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Sparrow Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 83 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, single-center, open-label, single-dose trial. Sixteen participants are planned: 8 participants with moderate renal impairment and 8 matched control participants with normal renal function.

Detailed description

Following Screening, enrolled participants will be confined to a clinical research unit for 6 days. Each participant will receive a single oral dose of clofutriben. Clofutriben PK, safety, and tolerability will be assessed. The participants will be contacted by telephone 4 weeks after clofutriben administration for safety follow-up.

Conditions

• Moderate Renal Impairment

Interventions

Type	Name	Description
DRUG	12mg clofutriben	Each participant will receive a single oral dose of clofutriben

Timeline

• Start date: 2025-11-30
• Primary completion: 2026-04-30
• Completion: 2026-07-01
• First posted: 2025-11-13
• Last updated: 2025-12-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study