Diabetes, Healthy
Conditions
Brief summary
This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) of multiple doses of NNC0113-0987 in an oral formulation in healthy subjects.
Interventions
DRUGNNC0113-0987
Tablets for once-daily oral administration. Multiple doses with sequential dose increments over 10 weeks. The end-dose levels and the dose levels during the escalation regime may be adapted during trial conduct based on safety evaluations.
DRUGplacebo
Tablets for one-daily 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
No
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 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 * Body mass index (BMI): 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, 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 syndrome type 2 * History of chronic pancreatitis or idiopathic acute pancreatitis * Subject with previous gastrointestinal surgery, except subjects that underwent uncomplicated surgical procedures such as appendectomy, hernia surgery, biopsies, as well as colonic and gastric endoscopy * Use of prescription or non-prescription medicinal products and herbal products (except routine vitamins) within three weeks preceding the dosing period. Occasional use of paracetamol or acetylsalicylic acid is permitted
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of treatment emergent adverse events 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 |
|---|---|
| Number of hypoglycaemic episodes | From the time of first dosing (day 0) and until completion of the post-treatment follow-up visit (day 83-97) |
| Area under the NNC0113-0987 plasma concentration time curve | During a dosing interval (0-24 hours) at steady state (day 67, day 68 and day 69) |
| Maximum observed NNC0113-0987 plasma concentration | During a dosing interval (0-24 hours) at steady state (day 67, day 68 and day 69) |
Countries
Germany
Outcome results
None listed