Trabalhos Aprovados

A study of drug-drug interactions of oral semaglutide with metformin and digoxin



Autor(es): Cavalari, EMR; Thomsen, M; emrc@novonordisk.com; Golor, G; Søndergaard, FL; Anderson, TW;
Apresentador(a): Emanuela Cavalari

Introduction:Oral semaglutide is a novel tablet in development for the treatment of type 2 diabetes, containing the human glucagon-like peptide-1(GLP-1) analog, semaglutide, and the absorption enhancer, sodium N-(8-[2-hydroxybenzoyl] amino)caprylate (SNAC). Objective:To investigate if oral semaglutide dosed at steady state concentrations influences the pharmacokinetic(PK) of metformin or digoxin. Methods:This was an open-label, one-sequence, crossover trial. On days 1-4, 32 healthy subjects were dosed with 850 mg metformin twice daily for 3 days and once daily on the 4th day. A single dose of 500μg digoxin (2 x 250μg tablets) was given on day 8. All morning doses were taken after an overnight fast followed by fasting for an additional 30 minutes. The evening metformin doses were taken 1 hour after dinner. From day 17, a similar pattern of metformin dosing took place (7 doses). Single doses of SNAC 300mg were dosed concomitantly with the morning metformin doses for assessment of the PK of metformin and SNAC. On day 24, subjects received a single dose of SNAC 300mg concomitantly with a single dose of 500 μg digoxin. Treatment with oral semaglutide started on day 33, at an initial once daily dose of 5mg for 1 week, then 10mg for 1 week and finally 20 mg for 4 weeks to reach steady state, with a final dose on day 87. From day 75 when oral semaglutide was at steady state, the final dosing pattern of metformin (7 doses) and digoxin (single dose) took place, both concomitantly with oral semaglutide. Results:The concentration−time curve(AUC) of metformin increased with oral semaglutide co-administration, while the maximum concentration(Cmax) of metformin and AUC and Cmax of digoxin were unaffected. SNAC alone did not affect the AUC or Cmax of metformin, indicating that the increase in the AUC of metformin observed with oral semaglutide was not due to any absorption enhancing effect of SNAC. There were no apparent effects of oral semaglutide on the half-life (t½) of metformin with geometric means of 16 h for metformin alone and 13h when co-administered with oral semaglutide.Similarly, there were no apparent effects of oral semaglutide on the t½ of digoxin, with geometric means of 42 versus 43h, respectively. The safety profile was as expected for the GLP-1ar drug class. No serious adverse events were reported. Conclusions:Oral semaglutide had no clinically relevant effect on the exposure of metformin or digoxin. No new safety concerns were identified in this trial.

Palavras-chave: Diabetes mellitus; Semaglutide; Drug interactions

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