Diabetes, Healthy
Conditions
Brief summary
This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of multiple doses of a long acting GLP-1 analogue (NNC0113-0987) in healthy male subjects.
Interventions
DRUGNNC0113-0987
Once-daily doses for oral administration. Multiple doses with sequential dose increments over 10 weeks. Progression to next dose increment is based on a safety evaluation
DRUGplacebo
Once-daily doses for oral administration
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, 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 * Age 18-64 years (both inclusive) at the time of signing informed consent * BMI (body mass index) 20.0-29.9 kg/m\^2 (both inclusive)
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 * Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 * History of chronic pancreatitis or idiopathic acute pancreatitis * Use of prescription or non-prescription medicinal and herbal products (except routine vitamins) within three weeks preceding the dosing period. Occasional use of paracetamol or acetylsalicylic acid is permitted * Subject with previous GI surgery, except subjects that underwent uncomplicated surgical procedures such as appendectomy, hernia surgery, biopsies, as well as colonic and gastric endoscopy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of treatment emergent adverse events (TEAEs) recorded | From the time of first dosing (Day 0) and until completion of the post-treatment follow-up visit (Day 83-97) |
Secondary
| Measure | Time frame |
|---|---|
| Maximum observed NNC0113-0987 plasma concentration | During a dosing interval (0-24 hours) at steady state (Day 67; Day 68 and Day 69) |
| Time to maximum observed NNC0113-0987 plasma concentration | During a dosing interval (0-24 hours) at steady state (Day 67; Day 68 and Day 69) |
| Area under the NNC0113-0987 plasma concentration curve | During a dosing interval (0-24 hours) at steady state (Day 67; Day 68 and Day 69) |
| Change in HbA1C (glycosylated haemoglobin) | From baseline (Day 0, pre-dose) to after 10 weeks of treatment (Day 70) |
| Change in body weight | From baseline (Day -1) to after 10 weeks of treatment (Day 70) |
| Change in fasting plasma glucose (FPG) | From baseline (Day 0, pre-dose) to after 10 weeks of treatment (Day 70) |
Countries
United Kingdom
Outcome results
None listed