Diabetes, Healthy
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to investigate the influence of oral semaglutide on pharmacokinetics (the exposure of the trial drug in the body) of metformin and digoxin in healthy subjects.
Interventions
DRUGsemaglutide
Oral administration of 5 mg daily for one week, then escalated to 10 mg daily for one week, followed by escalation to 20 mg daily for 41 days
DRUGmetformin
Oral administration of 850 mg twice daily for 3 days followed by 850 mg on day 4, assessed in 3 dosing periods 1) alone, 2) co-administration with SNAC (sodium N-\[8-(2-hydroxybenzoyl) amino\] caprylate) and 3) co-administration with oral semaglutide.
DRUGdigoxin
Oral administration of 0.5 mg single dose, assessed in 3 dosing periods 1) alone, 2) co-administration with SNAC (sodium N-\[8-(2-hydroxybenzoyl) amino\] caprylate) and 3) co-administration with oral semaglutide.
DRUGplacebo
Oral administration of SNAC 300 mg. Will be administered with the morning dose of metformin (1st, 3rd, 5th and 7th dose). On Day 24, a single SNAC dose will be administered with digoxin.
Sponsors
Novo Nordisk A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female, age 18-75 years (both inclusive) at the time of signing inform consent * Body mass index (BMI) 20.0-29.9 kg/m\^2 (both inclusive) * A good general health based on medical history, physical examination, and results of vital signs, electrocardiogram and laboratory safety tests performed during the screening visit, as judged by the investigator
Exclusion criteria
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods. Female of child bearing potential must use effective methods of birth control for the duration of the trial and for 5 weeks following last dose. Only highly effective methods of birth control are accepted (i.e., one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices) * History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease * Hypertension (defined as sitting systolic blood pressure above 140 mmHg and/or diastolic blood pressure above 90 mmHg). If white-coat hypertension is suspected at the screening visit a repeated measurement is allowed * Any blood draw in excess of 25 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the metformin plasma concentration-time curve | During a dosing interval (0 to12 hours) at steady state |
| Area under the digoxin plasma concentration-time curve | From time 0 to infinity after single dose |
Secondary
| Measure | Time frame |
|---|---|
| Maximum observed semaglutide plasma concentration | During a dosing interval (0 to 24 hours) at steady state |
| Maximum observed metformin plasma concentration | During a dosing interval (0 to 12 hours) at steady state |
| Number of hypoglycaemic episodes | From the first dosing (Day 1) and until completion of the post treatment follow up visit (Day 118-122) |
| Area under the SNAC plasma concentration-time curve | During a dosing interval (0 to 24 hours) at steady state |
| Maximum observed digoxin plasma concentration | 0 to 120 hours after single dose |
Countries
Germany
Outcome results
None listed