Investigating the Influence of Semaglutide on the Pharmacokinetics of Single Doses of Atorvastatin and Digoxin in Healthy Subjects

Phase 1 Completed 31 enrolled Novo Nordisk A/S

Non-randomizedCrossoverOpen-labelBasic science

Summary

The trial is conducted in Europe. The aim of the trial is to investigate the influence of semaglutide on the pharmacokinetics (the exposure of the trial drug in the body) of single doses of atorvastatin and digoxin in healthy subjects.

Timeline

Start: 2014-09-16
Primary completion: 2015-04-07
Completion: 2015-04-07

Outcome

Met primary endpoint

paper Estimated area under the plasma concentration-time curve ratios for all concomitant medications before and with semaglutide treatment were within the pre-specified interval. PMID 28349387 ↗

Publications

Results Hausner H, Derving Karsbol J, Holst AG, Jacobsen JB, Wagner FD, Golor G, Anderson TW. Effect of Semaglutide on the Pharmacokinetics of Metformin, Warfarin, Atorvastatin and Digoxin in Healthy Subjects. Clin Pharmacokinet. 2017 Nov;56(11):1391-1401. doi: 10.1007/s40262-017-0532-6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Atorvastatin	Small molecule	40 mg	Oral
Subject	Digoxin	Other / unclassified	0.5 mg	Oral
Subject	Semaglutide	Peptide	1 mg	Subcutaneous