Novo Nordisk Investigational Site
Berlin, 14050, Germany
NCT Number: NCT03466567
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.
Looking for future studies?
Notify Me18 year–64 year
All sexes
Interventional
Phase 1
Berlin, 14050, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A single dose of 3 mg semaglutide tablet alone will be administered orally. Trial product administration will take place in the morning after overnight fasting for at least 6 hours.
A dose of 500 mg probenecid (2 tablets of 250 mg) will be administered orally twice daily for 3½ days (7 trial product administrations in total). On the 4th day, the last probenecid administration will take place 2 hours prior to administration of a single dose of 3 mg oral semaglutide tablet. The last trial product administrations will take place in the morning after overnight fasting for at least 6 hours.
A single dose of 600 mg ciclosporin (6 capsules of 100 mg) will be administered orally 1 hour prior to administration of a single dose of 3 mg oral semaglutide tablet. Trial product administration will take place in the morning after overnight fasting for at least 6 hours.
Time frame: 0-48 hours
Calculated based on plasma SNAC activity measured in blood.
Time frame: 0-48 hours
Calculated based on plasma SNAC activity measured in blood.
Time frame: 0-48 hours
Calculated based on plasma SNAC metabolite E494 activity measured in blood.
Time frame: 0-48 hours
Calculated based on plasma SNAC metabolite E494 activity measured in blood.
Time frame: 0-48 hours
Calculated based on plasma SNAC metabolite E506 activity measured in blood.
Time frame: 0-48 hours
Calculated based on plasma SNAC metabolite E506 activity measured in blood.
Time frame: 0-48 hours
Calculated based on plasma SNAC metabolite E1245 activity measured in blood.
Time frame: 0-48 hours
Calculated based on plasma SNAC metabolite E1245 activity measured in blood.
Time frame: 0-48 hours
Calculated based on plasma SNAC metabolite E1246 activity measured in blood.
Time frame: 0-48 hours
Calculated based on plasma SNAC metabolite E1246 activity measured in blood.
Time frame: 0-48 hours
Calculated based on plasma SNAC metabolite E1247 activity measured in blood.
Time frame: 0-48 hours
Calculated based on plasma SNAC metabolite E1247 activity measured in blood.
Novo Nordisk A/S
Industry
A Trial Investigating the Effect of Probenecid and Ciclosporin on the Pharmacokinetics of SNAC in Healthy Subjects
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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