Clofutriben Pharmacokinetics in Patients With Impaired Renal Function
ConditionModerate Renal Impairment
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-83
SponsorSparrow Pharmaceuticals
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- 12mg clofutriben
Treatment groups
16 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov