Clofutriben Pharmacokinetics in Patients With Impaired Renal Function

Phase 1RecruitingNCT07227922

Sparrow Pharmaceuticals16 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Moderate Renal Impairment

Interventions

12mg clofutribenDRUG

Each participant will receive a single oral dose of clofutriben

Eligibility

Sex: ALLMin age: 18 YearsMax age: 83 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Orlando Clinical Research Center

Orlando, Florida, United States

RECRUITING

Outcomes

Primary Outcomes

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.

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.

Data from ClinicalTrials.gov

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