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

What Was Tested

The trial (phase 1) is built around Semaglutide.

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.

It had three arms (groups): Oral semaglutide, ciclosporin, probenecid (experimental), Probenecid, oral semaglutide, ciclosporin (experimental) and Ciclosporin, probenecid, oral semaglutide (experimental).

Participants will receive oral semaglutide in treatment period 1, ciclosporin in treatment period 2, and probenecid in treatment period 3.

Participants will receive probenecid in treatment period 1, oral semaglutide in treatment period 2, and ciclosporin in treatment period 3.

Participants will receive ciclosporin in treatment period 1, probenecid in treatment period 2, and oral semaglutide in treatment period 3.

The registry classes the interventions as drug.

Who Took Part

21 actual participants took part.

It was open to people of any sex aged from 18 years up to 64 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Male or female of non-childbearing potential, aged 18-64 years (both inclusive) at the time of signing informed consent. Body mass index between 18.5 and 29.9 kg/sqm (both inclusive). Body weight greater than or equal to 50.0 kg.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: known glucose-6-phosphate-dehydrogenase deficiency (as declared by the subject).

How the Study Was Run

The set-up was randomized, crossover and open-label.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

Each person switched between Semaglutide and the comparison at some point, usually with a gap in between.

Nothing was hidden in this open-label Semaglutide study: the participants and staff both knew the treatment.

It started in 2018-03-15 with completion listed for 2018-07-10.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 21 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.