NCT04178447

Pharmacokinetic Profile of Glepaglutide After a Single Injection in Subjects With Varying Degrees of Renal Function

An Open-label, Multi-center Trial to Evaluate the Pharmacokinetic Profile of Glepaglutide After a Single Subcutaneous Injection in Subjects With Varying Degrees of Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Zealand Pharma · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This is two stage design, open-label, multi-center, non-randomized trial evaluating the PK of a single, subcutaneous dose of 10 mg glepaglutide in subjects with varying degrees of renal function. The renal function will be calculated by the estimated glomerular filtration rate (eGFR) according to the Modification of Diet in Renal Disease (MDRD) equation.

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	Glepaglutide	Single dose of Glepaglutide 10 mg

Timeline

• Start date: 2019-12-10
• Primary completion: 2020-07-14
• Completion: 2020-07-14
• First posted: 2019-11-26
• Last updated: 2020-11-18

Locations

3 sites across 2 countries: Hungary, Poland

Regulatory

• FDA-regulated drug study