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A Trial Investigating the Effect of Probenecid and Ciclosporin on the Concentrations of SNAC in Healthy Subjects - Trial NCT03466567

Access comprehensive clinical trial information for NCT03466567 through Pure Global AI's free database. This Phase 1 trial is sponsored by Novo Nordisk A/S and is currently Completed. The study focuses on Diabetes,Diabetes Mellitus, Type 2. Target enrollment is 21 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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NCT03466567
Phase 1
Completed
drug
Trial Details
ClinicalTrials.gov • NCT03466567
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A Trial Investigating the Effect of Probenecid and Ciclosporin on the Concentrations of SNAC in Healthy Subjects
A Trial Investigating the Effect of Probenecid and Ciclosporin on the Pharmacokinetics of SNAC in Healthy Subjects

Study Focus

Semaglutide

Interventional

drug

Sponsor & Location

Novo Nordisk A/S

Berlin, Germany

Timeline & Enrollment

Phase 1

Mar 15, 2018

Jul 10, 2018

21 participants

Primary Outcome

AUC0-tz,SNAC,SD, area under the SNAC plasma concentration-time curve from time 0 to time of the last quantifiable concentration after a single dose of oral semaglutide,Cmax,SNAC,SD, maximum observed SNAC plasma concentration on the concentration-time curve after a single dose of oral semaglutide

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.

ICD-10 Classifications

Type 2 diabetes mellitus
Type 2 diabetes mellitus with other specified complications
Type 2 diabetes mellitus with unspecified complications
Type 2 diabetes mellitus without complications
Type 2 diabetes mellitus with multiple complications

Data Source

ClinicalTrials.gov

NCT03466567

Non-Device Trial