A Phase 1 Study to Evaluate the Pharmacokinetics of Setmelanotide in Subjects With Varying Degrees of Renal Impairment
Status:
Completed
Trial end date:
2021-04-17
Target enrollment:
Participant gender:
Summary
This is a Phase 1, multi-center, open-label, single-dose study designed to assess the effect
of renal impairment on the PK of setmelanotide. A total of approximately 32 subjects
(approximately 8 subjects in each renal impairment group and 8 healthy subjects with normal
renal function) are planned to be enrolled across 4 centers in the United States. At
screening, subjects will be assigned to a study group according to eGFR.
Cohort A - Mild Renal Impairment
Cohort B - Moderate Renal Impairment
Cohort C - Severe Renal Impairment
Cohort D - Normal Renal Function (control)