Clofutriben Pharmacokinetics in Patients With Impaired Renal Function (RENAL)

Sparrow Pharmaceuticals

Status and phase: Enrolling; Phase 1

Conditions: Moderate Renal Impairment

Treatments: Drug: 12mg clofutriben

Study type: Interventional

Funder types: Industry

Identifiers

NCT07227922

SPI-62-CL-1005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 83 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

clofutriben

Experimental group

Treatment:

Drug: 12mg clofutriben