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

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.

Timeline

Start

2019-12-10

Primary completion

2020-07-14

Completion

2020-07-14

Publications

• Agersnap MA, Sonne K, Knudsen KM, Sulowicz W. Pharmacokinetics, Safety, and Tolerability of Glepaglutide, a Long-Acting GLP-2 Analog, in Subjects with Renal Impairment. Clin Pharmacokinet. 2023 Apr;62(4):645-651. doi: 10.1007/s40262-023-01215-9. Epub 2023 Feb 21.

Drugs

Indications