A Thorough QTc Trial Evaluating the Effect of SNAC on Cardiac Repolarisation in Healthy Male Subjects.

Phase 1 Completed 84 enrolled Novo Nordisk A/S

RandomizedCrossoverDouble-blindTreatment

Summary

This trial is conducted in Europe. The aim of this trial is to evaluate the effect of SNAC on cardiac repolarisation in healthy male subjects

Timeline

Start: 2016-09-23
Primary completion: 2017-05-04
Completion: 2017-05-11

Outcome

Met primary endpoint

paper There was no unacceptable prolongation of the QTcF interval with SNAC 3.6 g, and assay sensitivity was demonstrated with moxifloxacin as the positive control. PMID 34319564 ↗

Publications

Granhall C, Baekdal TA, Breitschaft A, Sondergaard FL, Anderson TW, Thomsen M. Absence of QTc Prolongation with Sodium N-(8-[2-Hydroxybenzoyl] Amino) Caprylate (SNAC), an Absorption Enhancer Co-Formulated with the GLP-1 Analogue Semaglutide for Oral Administration. Diabetes Ther. 2021 Sep;12(9):2599-2610. doi: 10.1007/s13300-021-01106-x. Epub 2021 Jul 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Moxifloxacin	Small molecule	400 mg	Oral
Subject	sodium N-(8-[2-hydroxybenzoyl] amino) caprylate	Unknown	1.2 g	Oral
Subject	sodium N-(8-[2-hydroxybenzoyl] amino) caprylate	Unknown	2.4 g	Oral
Subject	sodium N-(8-[2-hydroxybenzoyl] amino) caprylate	Unknown	3.6 g	Oral

Indications

No indication recorded.