Diabetes, Diabetes Mellitus, Type 2, Healthy
Conditions
Brief summary
This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability and pharmacokinetics (the effect of the investigated drug on the body) of single and multiple doses of a long-acting GLP-1 analogue (semaglutide) in an oral formulation in healthy male subjects.
Interventions
DRUGsemaglutide
A maximum of six single-dose cohorts of oral semaglutide administered according to an ascending dose design. Starting dose 2 mg, max. dose 60 mg. Progression to next dose will be based on safety evaluation. Sequential cohorts.
DRUGplacebo
In each cohort of 10, eight subjects will randomised to active treatment and two to placebo.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Male subject, who is considered to be generally healthy, based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and laboratory safety tests performed during the screening visit, as judged by the investigator * Body Mass Index (BMI) between 20 and 30 kg/m\^2 * Glycosylated haemoglobin (HbA1c) below 6.0% (only in Part B)
Exclusion criteria
* History of, or presence of, cancer, diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal (GI), endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator * Use of prescription or non-prescription medicinal and herbal products (except routine vitamins) within three weeks preceding the dosing. Occasional use of paracetamol or acetylsalicylic acid is permitted
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: Number of treatment emergent adverse events (TEAEs) | Day -1 to Day 24 |
| Part B: Number of treatment emergent adverse events (TEAEs) | Recorded from the time of first dosing (Visit 3, Day -1 to day +2) and until completion of the post treatment follow-up visit (Visit 18, Day 90-104) |
Secondary
| Measure | Time frame |
|---|---|
| Part A: AUC0-24h,semaglutide: the area under the semaglutide plasma concentration curve | From time 0 to 24 hours after a single dose (Day 0) |
| Part B: AUCτ,semaglutide: area under the semaglutide plasma concentration curve | Over the dosing interval (0-24 hours) after the last 3 daily doses (Days 67-69) |
| Part B: Change in fasting plasma glucose (FPG) from baseline | Day 0 (pre-dose), day 70 |
| Part B: Change in body weight from baseline | Day -1, day 70 |
Countries
Germany
Outcome results
None listed