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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: Probenecid; Drug: Ciclosporin; Drug: Semaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT03466567

U1111-1197-9088 (Other Identifier)

NN9924-4394

2017-002498-21 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.
• Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion criteria

• Use of tobacco and nicotine products, defined as: A. Smoking more than 1 cigarette or the equivalent per day B. Not able or willing to refrain from smoking and use of nicotine substitute products during the in-house period(s).

• Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator.
• History (as declared by the subject) of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
• Known glucose-6-phosphate-dehydrogenase deficiency (as declared by the subject).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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21 participants in 3 patient groups

Oral semaglutide, ciclosporin, probenecid

Experimental group

Description:

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

Treatment:

Drug: Probenecid

Drug: Semaglutide

Drug: Ciclosporin

Probenecid, oral semaglutide, ciclosporin

Experimental group

Description:

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

Treatment:

Drug: Probenecid

Drug: Semaglutide

Drug: Ciclosporin

Ciclosporin, probenecid, oral semaglutide

Experimental group

Description:

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

Treatment:

Drug: Probenecid

Drug: Semaglutide

Drug: Ciclosporin