Clofutriben Pharmacokinetics in Patients With Impaired Renal Function (RENAL)

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.

Study Overview

• Status: Recruiting
• Conditions: Moderate Renal Impairment
• Intervention / Treatment: Drug: 12mg clofutriben

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.

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32809
      • Recruiting
      • Orlando Clinical Research Center
      • Contact: Rhyan Clinical Research Manager; Phone Number: 407.472.0225; Email: rdumontlorenzo@ocrc.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: clofutriben	Drug: 12mg clofutriben; Each participant will receive a single oral dose of clofutriben

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Maximum plasma concentration (Cmax)	Conclusions that clofutriben and AS2570469 exposures (separately) are not altered by moderate renal impairment will be reached if the 95% CIs of the geometric mean estimates of AUC0-t, AUC0-inf, and Cmax of clofutriben and AS2570469 fall within the [60%, 140%] range.	from enrollment through treatment for 6 days.
2. Area under the plasma time-concentration curve (AUC0-t, AUC0-inf)	Conclusions that clofutriben and AS2570469 exposures (separately) are not altered by moderate renal impairment will be reached if the 95% CIs of the geometric mean estimates of AUC0-t, AUC0-inf, and Cmax of clofutriben and AS2570469 fall within the [60%, 140%] range.	from enrollment through treatment for 6 days.

Collaborators and Investigators

• Sponsor: Sparrow Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2025
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: November 6, 2025
• First Submitted That Met QC Criteria: November 11, 2025
• First Posted (Estimated): November 13, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Renal
• Other Study ID Numbers: SPI-62-CL-1005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No