A Trial Investigating the Effect of Oral Semaglutide on the Pharmacokinetics of Furosemide and Rosuvastatin in Healthy Subjects

Phase 1 Completed 41 enrolled Novo Nordisk A/S

NaSingle-groupOpen-labelTreatment

Summary

This trial is conducted in Europe. Tha aim of this trial is to investigate the effect of oral semaglutide on the pharmacokinetics of furosemide and rosuvastatin in healthy subjects.

Timeline

Start: 2017-01-05
Primary completion: 2017-06-04
Completion: 2017-08-09

Outcome

Missed primary endpoint

paper The no-effect criterion was not met for furosemide or rosuvastatin for the AUC (1.28 [1.16-1.42] and 1.41 [1.24-1.60], respectively) or Cmax. PMID 33782832 ↗

Publications

Jordy AB, Albayaty M, Breitschaft A, Anderson TW, Christiansen E, Houshmand-Oregaard A, Manigandan E, Baekdal TA. Effect of Oral Semaglutide on the Pharmacokinetics of Levonorgestrel and Ethinylestradiol in Healthy Postmenopausal Women and Furosemide and Rosuvastatin in Healthy Subjects. Clin Pharmacokinet. 2021 Sep;60(9):1171-1185. doi: 10.1007/s40262-020-00976-x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Furosemide	Other / unclassified	—	Oral
Subject	Rosuvastatin	Small molecule	—	Oral
Subject	Semaglutide	Peptide	—	Oral
Subject	sodium N-(8-[2-hydroxybenzoyl] amino) caprylate	Unknown	—	Oral