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Clofutriben Pharmacokinetics in Patients With Impaired Renal Function

NCT ID: NCT07227922

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2026-07-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Moderate Renal Impairment

Keywords

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Renal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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clofutriben

Group Type EXPERIMENTAL

12mg clofutriben

Intervention Type DRUG

Each participant will receive a single oral dose of clofutriben

Interventions

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12mg clofutriben

Each participant will receive a single oral dose of clofutriben

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

83 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sparrow Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Orlando Clinical Research Center

Orlando, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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SPI-62-CL-1005

Identifier Type: -

Identifier Source: org_study_id