Recruiting
Phase 1

Observational Study

Sponsor:

Sparrow Pharmaceuticals

Code:

NCT07227922

Conditions

Moderate Renal Impairment

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

12mg clofutriben

Study Details

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

Study ID

NCT07227922

Start date

Nov 30, 2025

Status verified date

Nov, 2025

Completion date

Jul 1, 2026

Anticipated

Primary completion date

Apr 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

16 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: clofutriben

Interventions

12mg clofutriben

Each participant will receive a single oral dose of clofutriben

Primary outcome measure

  • 1. Maximum plasma concentration (Cmax) [ Time Frame: from enrollment through treatment for 6 days. ]
  • 2. Area under the plasma time-concentration curve (AUC0-t, AUC0-inf) [ Time Frame: from enrollment through treatment for 6 days. ]

Central Contacts and Locations

Locations

Orlando Clinical Research Center

Recruiting

Orlando, Florida, United States, 32809

Contacts

Rhyan Clinical Research Manager

407.472.0225rdumontlorenzo@ocrc.net

More Information

Sponsor

Sparrow Pharmaceuticals

Last update posted

Dec 23, 2025

Last verified

Nov, 2025

Keywords

  • Renal

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sparrow Pharmaceuticals on 2025-12-23.