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NCT Number: NCT07227922

Clofutriben Pharmacokinetics in Patients With Impaired Renal Function

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.

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Key information

Conditions

Moderate Renal Impairment

Age range

18 year–83 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location status: Recruiting

Location contact

Rhyan Clinical Research Manager

CONTACT

[email protected]

407.472.0225

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

12mg clofutriben

Drug

Each participant will receive a single oral dose of clofutriben

Primary outcomes

  1. 1. Maximum plasma concentration (Cmax)

    Time frame: from enrollment through treatment for 6 days.

    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.

  2. 2. Area under the plasma time-concentration curve (AUC0-t, AUC0-inf)

    Time frame: from enrollment through treatment for 6 days.

    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.

Sponsors and collaborators

Lead sponsor

Sparrow Pharmaceuticals

Industry

Registry information

Acronym: RENAL

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 13, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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