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
This trial accepts healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
12mg clofutriben
DrugEach participant will receive a single oral dose of clofutriben
Treatment groups
16 Participants
are divided into 1 treatment groupGroup A: clofutribenExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
2. Area under the plasma time-concentration curve (AUC0-t, AUC0-inf)
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov