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

NCT04348175 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2021-06-30

No results posted yet for this study

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)

Conditions

  • Renal Insufficiency

Interventions

DRUG

Setmelanotide

Setmelanotide will be administered as a single SC dose of 2.0 mg on Day 1. A dose higher than 2.0 mg will not be used during the study. Dose may be lowered based on safety data.

Sponsors & Collaborators

  • Rhythm Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
83 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-09
Primary Completion
2021-04-17
Completion
2021-04-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04348175 on ClinicalTrials.gov