Clofutriben Pharmacokinetics in Patients With Impaired Renal Function

NCT07227922 | Recruiting Phase 1 FDA Drug

• 1 other identifier: SPI-62-CL-1005
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Moderate Renal Impairment

Keywords

Renal

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (1)

clofutriben

EXPERIMENTAL

Drug: 12mg clofutriben

Interventions

12mg clofutriben DRUG

Each participant will receive a single oral dose of clofutriben

clofutriben

Eligibility Criteria

• Age: 18 Years - 83 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sparrow Pharmaceuticals: lead

Study Sites (1)

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2025
• First Posted: November 13, 2025
• Study Start: November 30, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-11

Locations

US (1)