Study of Pharmacokinetics and Safety of Apraglutide in Participants With Normal and Impaired Kidney Function.

NCT04699032 ↗

Phase 1 Completed 16 enrolled VectivBio AG

Non-randomizedParallel-groupOpen-labelTreatment

Summary

Study of pharmacokinetics and safety of apraglutide in participants with normal and impaired kidney function.

Timeline

Start: 2020-12-08
Primary completion: 2021-07-05
Completion: 2021-07-05

Outcome

Met primary endpoint

paper The respective geometric mean ratios were 0.620 and 0.693 for Cmax and AUCinf, and the upper bound of their 90% confidence intervals were <2 PMID 38465515 ↗

paper patients with severe renal impairment were not overexposed to apraglutide versus those with normal renal function PMID 38465515 ↗

Publications

Greig G, Youssef NN, Bolognani F. Pharmacokinetics and Tolerability of a Single Dose of Apraglutide, a Novel, Long-Acting, Synthetic glucagon-like peptide-2 Analog With a Unique Pharmacologic Profile, in Individuals With Impaired Renal Function. J Clin Pharmacol. 2024 Jun;64(6):744-754. doi: 10.1002/jcph.2423. Epub 2024 Mar 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Apraglutide	Peptide	5 mg	Subcutaneous