Clofutriben Pharmacokinetics in Patients With Impaired Renal Function
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 12mg clofutriben.
- Who it may be relevant to
- Registry conditions: Moderate Renal Impairment. Basic parameters: 18 years — 83 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Detailed description
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.
Interventions
- Drug 12mg clofutriben
Each participant will receive a single oral dose of clofutriben
Primary outcome measures
- 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Orlando Clinical Research Center — Orlando
Identifiers
NCT: NCT07227922 · SPI-62-CL-1005