12mg clofutriben: Each participant will receive a single oral dose of clofutriben
Study summary
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
Sex
ALL
Min age
18 Years
Max age
83 Years
Healthy volunteers
Accepted
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
Primary outcome measure(s)
1. Maximum plasma concentration (Cmax) — from enrollment through treatment for 6 days. 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.
2. Area under the plasma time-concentration curve (AUC0-t, AUC0-inf) — from enrollment through treatment for 6 days. 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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