Healthy Volunteers, Type 2 Diabetes
Conditions
Brief summary
In this study NN0113-6856 will be given to humans for the first time. We will be looking into how safe different single doses of the new investigational product NNC0113-6856 is and we will measure its amount as well as the amount of specific parts of the new investigational product in blood. The study will look at the effects of different single doses of NNC0113-6856. This could either be as an oral dose (cohort 1 to 5) or one injection into the vein (intravenous \[IV\]-cohort). Participant will get the investigational product either as one or two tablets (oral dose in cohort 1 to 5) or as injection into the vein (IV cohort). The study will last for about 6-10 weeks (up to 14 weeks in case of rescheduling for stand-by participants).
Interventions
DRUGNNC0113-6856
Participants will receive NN0113-6856 orally or intravenously.
DRUGPlacebo
Participants will receive matching placebo of NNC0113-6856 for each of the oral cohorts.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Male. * Aged 18-55 years (both inclusive) at the time of signing informed consent. * Body mass index between 20.0 and 27.0 kilogram per meter square (kg/m\^2)(both inclusive).
Exclusion criteria
* Glycated haemoglobin (HbA1c) greater than or equal to (\>=) 6.5 percent (%) (48 millimoles per moles \[mmol/mol\]) at screening. * Use of tobacco and nicotine products, defined as any of the below: * Smoking more than 5 cigarettes or the equivalent per day. * Not willing to refrain from smoking and use of nicotine substitute products during the inpatient periods. * Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator. * History of major surgical procedures involving the stomach potentially affecting absorption of trial products (example: subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant * Presence or history of pancreatitis (acute or chronic). * Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. * Any of the below laboratory safety parameters at screening outside the below laboratory range, see Log of laboratory ranges used for laboratory parameter exclusion criterion for specific values: * Alanine Aminotransferase (ALT) greater than (\>) upper normal limit (UNL) * Aspartate aminotransferase (AST) \> UNL * Bilirubin \> UNL * Creatinine \> UNL * International normalized ratio (INR) \> UNL * Precence or history of hepatitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events | From time of dosing (day 1) until completion of the follow-up visit (Day 42) | Measured as number of events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| For oral cohorts- AUC0-infinity (∞),sema,SD: Area under the semaglutide plasma concentration-time curve from time 0 to infinity after a single dose | From pre-dose (day 1) to completion of follow-up visit (Day 42) | Measured in hours\*nanomoles per liter (h\*nmol/L). |
| For oral cohorts- Cmax,sema,SD: Maximum observed plasma concentration of semaglutide after a single dose | From pre-dose (day 1) to completion of follow-up visit (day 42) | Measured in nanomoles per liter (nmol/L). |
| For oral cohorts- tmax,sema,SD: Time to maximum observed concentration of semaglutide after a single dose | From pre-dose (day 1) to completion of follow-up visit (day 42) | Measured in hours (h). |
| For oral cohorts- t½,sema,SD: Terminal half-life of semaglutide after a single dose | From pre-dose (day 1) to completion of follow-up visit (day 42) | Measured in hours (h). |
| For oral cohorts- AUC0-tz,6856,SD: Area under the NNC0113-6856 plasma concentration-time curve from time 0 to tz after a single dose, where tz is the time of last quantifiable concentration | From pre-dose (day 1) to completion of visit 5 (day 22) | Measured in hours\*nanomoles per liter (h\*nmol/L). |
| For oral cohorts- AUC0-∞,6856,SD: Area under the NNC0113-6856 plasma concentration-time curve from time 0 to infinity after a single dose | From pre-dose (day 1) to completion of visit 5 (day 22) | Measured as hours\*nanomoles per liter (h\*nmol/L). |
| For oral cohorts- Cmax,6856,SD: Maximum observed plasma concentration of NNC0113-6856 after a single dose | From pre-dose (day 1) to completion of visit 5 (day 22) | Measured as nanomoles per liter (nmol/L). |
| For oral cohorts- tmax,6856,SD: Time to maximum observed concentration of NNC0113-6856 after a single dose | From pre-dose (day 1) to completion of visit 5 (Day 22) | Measured in hours (h). |
| For oral cohorts- t½,6856,SD: Terminal half-life of NNC0113-6856 after a single dose | From pre-dose (day 1) to completion of visit 5 (Day 22) | Measured in hours (h). |
| For oral cohorts- AUC0-tz,4768,SD: Area under the NNC0113-4768 plasma concentration-time curve from time 0 to tz after a single dose, where tz is the time of last quantifiable concentration | From pre-dose (day 1) to completion of visit 5 (Day 22) | Measured in hours\*nanomoles per liter (h\*nmol/L). |
| For oral cohorts- AUC0-∞,4768,SD: Area under the NNC0113-4768 plasma concentration-time curve from time 0 to infinity after a single dose | From pre-dose (day 1) to completion of visit 5 (Day 22) | Measured in hours\*nanomoles per liter (h\*nmol/L). |
| For oral cohorts- Cmax,4768,SD: Maximum observed plasma concentration of NNC0113-4768 after a single dose | From pre-dose (day 1) to completion of visit 5 (Day 22) | Measured in nanomoles per liter (nmol/L). |
| For oral cohorts- AUC0-tz,sema,single dose (SD): Area under the semaglutide plasma concentration-time curve from time 0 to tz after a single dose, where tz is the time of last quantifiable concentration | From pre-dose (day 1) to completion of follow-up visit (Day 42) | Measured in hours\*nanomoles per liter (h\*nmol/L). |
| For oral cohorts- t½,4768,SD: Terminal half-life of NNC0113-4768 after a single dose | From pre-dose (day 1) to completion of visit 5 (Day 22) | Measured in hours (h). |
| For intravenous (i.v.) cohort- AUC0-infinity (∞),sema,SD: Area under the semaglutide plasma concentration-time curve from time 0 to infinity after a single dose | From pre-dose (day 1) to completion of follow-up visit (day 42) | Measured in hours\*nanomoles per liter (h\*nmol/L). |
| For i.v. cohort- t½,sema,SD: Terminal half-life of semaglutide after a single dose | From pre-dose (day 1) to completion of follow-up visit (day 42) | Measured in hours (h). |
| For i.v. cohort- Cmax,sema,SD: Maximum observed plasma concentration of semaglutide after a single dose | From pre-dose (day 1) to completion of follow-up visit (day 42) | Measured in nanomoles per liter (nmol/L). |
| For i.v. cohort- AUC0-∞,6856,SD: Area under the NNC0113-6856 plasma concentration-time curve from time 0 to infinity after a single dose | From pre-dose (day 1) to completion of visit 5 (day 22) | Measured as hours\*nanomoles per liter (h\*nmol/L) |
| For i.v. cohort- t½,6856,SD: Terminal half-life of NNC0113-6856 after a single dose | From pre-dose (day 1) to completion of visit 5 (day 22) | Measured in hours (h). |
| For i.v. cohort- CL6856,SD: Total plasma clearance of NNC0113-6856 after a single dose | From pre-dose (day 1) to completion of visit 5 (Day 22) | Measured in liters per hour (L/h). |
| For i.v. cohort- Vz6856,SD: Apparent volume of distribution of NNC0113-6856 after a single dose based on plasma concentration values | From pre-dose (day 1) to completion of visit 5 (Day 22) | Measured in liters (L). |
| For i.v. cohort- MRT6856,SD: Mean residence time for NNC0113-6856 after a single dose | From pre-dose (day 1) to completion of visit 5 (Day 22) | Measured in hours (h). |
| For i.v. cohort- AUC0-infinity (∞),4768,SD: Area under the NNC0113-4768 plasma concentration-time curve from time 0 to infinity after a single dose | From pre-dose (day 1) to completion of visit 5 (Day 22) | Measured in hours\*nanomoles per liter (h\*nmol/L). |
| For i.v. cohort- t½,4768,SD: Terminal half-life of NNC0113-4768 after a single dose | From pre-dose (day 1) to completion of visit 5 (Day 22) | Measured in hours (h). |
| For i.v. cohort and oral cohort- AUC0-∞,6856,SD/dose: Area under the NNC0113-6856 plasma concentration-time curve from 0 to infinity after a single dose divided by the dose administered | From pre-dose (day 1) to completion of visit 5 (Day 22) | Measured in hours\*nanomoles per liter per milligram (h\*nmol/L/mg). |
| For oral cohorts- tmax,4768,SD: Time to maximum observed concentration of NNC0113-4768 after a single dose | From pre-dose (day 1) to completion of visit 5 (Day 22) | Measured in hours (h). |
Countries
Germany
Outcome results
None listed