RecruitingPhase 1NCT07227922

Clofutriben Pharmacokinetics in Patients With Impaired Renal Function

Sponsor

Sparrow Pharmaceuticals

Enrollment

16 participants

Start Date

Nov 30, 2025

Study Type

INTERVENTIONAL

Conditions

Moderate Renal Impairment

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.

Eligibility

Min Age: 18 YearsMax Age: 83 Years

Inclusion Criteria1

Male and female participants with stable moderate renal impairment (estimated glomerular filtration rate \[eGFR\]: 30 to <60 mL/min) and matched (by sex, age, and weight) control participants with normal renal function (eGFR: ≥90 mL/min) will be enrolled in this trial.

Exclusion Criteria1

Participant whose current or recent medical conditions, medications, or procedures could increase participant's safety risk, or whom the Investigator considers not suitable for entry into the trial or the participant, or who has clinically significant abnormal 12-lead electrocardiogram (ECG)/ vital sign measurements/ laboratory test results at Screening and Check-in, will not be enrolled

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Interventions

DRUG12mg clofutriben

Each participant will receive a single oral dose of clofutriben

Locations(1)

Orlando Clinical Research Center

Orlando, Florida, United States

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NCT07227922