Clofutriben Pharmacokinetics in Patients With Impaired Renal Function
Sparrow Pharmaceuticals
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.
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.
Eligibility
- Age range
- 18–83 years
- Sex
- All
- Healthy volunteers
- Yes
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 electrocardio…
Interventions
- Drug12mg clofutriben
Each participant will receive a single oral dose of clofutriben
Location
- Orlando Clinical Research CenterOrlando, Florida