drugset / Trial / NCT03466567

A Trial Investigating the Effect of Probenecid and Ciclosporin on the Concentrations of SNAC in Healthy Subjects

NCT03466567

Phase 1 Completed 21 enrolled Novo Nordisk A/S
RandomizedCrossoverOpen-labelTreatment

Summary

The aim of the study is to investigate the effect of the medicines, probenecid and ciclosporin on the concentrations of SNAC. SNAC is an ingredient of the semaglutide tablets. Participants will get 3 different treatments (that is 3 treatment periods): 1) a single dose of 3 mg semaglutide, 2) a single dose of 600 mg ciclosporin with 3 mg semaglutide, 3) 500 mg probenecid twice a day for 3 ½ days with a single dose of 3 mg semaglutide on the last day. The sequence of treatments participants get is decided by chance. Probenecid and ciclosporin are available medicines. They are given by doctors. Semaglutide contains SNAC. It cannot be prescribed yet. The study will last for up to 125 days. Participants will have 17 to 18 visits at the study centre. This includes short visits at the centre for blood sampling only. Participants will have several blood draws.

Timeline

Start
2018-03-15
Primary completion
2018-07-10
Completion
2018-07-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclosporine Peptide 600 mg Oral
Subject Probenecid Small molecule 500 mg Oral
Subject Semaglutide Peptide 3 mg Oral