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A Phase 1 Study to Evaluate the Pharmacokinetics of Setmelanotide in Subjects With Varying Degrees of Renal Impairment

Renal Insufficiency Clinical Trial

Official title:
A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of Setmelanotide in Subjects With Varying Degrees of Renal Impairment

Clinical Trial 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)

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04348175
Study type Interventional
Source Rhythm Pharmaceuticals, Inc.
Contact
Status Completed
Phase Phase 1
Start date July 9, 2020
Completion date April 17, 2021
View Details
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