Healthy Participants
Conditions
Brief summary
This study is testing a new study medicine which may be used to treat people with type 2 diabetes. NNC0650-0013 is a new medicine, which cannot be prescribed by doctors. The purpose of the study is to see if the new study medicine is safe, and how it works in participants body. Participants will get a single dose of the study medicine either as injection(s) under the skin or into a vein. The injection will be given by the study staff. If participants are chosen to get the study medicine as injections under the skin, participants will either get NNC0650-0013 or placebo (a dummy medicine without any active ingredients). Which treatment participants get is decided by chance. Participants will be required to fast overnight 3 times during the study. The study will last between 11 and 17 weeks.
Interventions
DRUGNNC0650-0013 A
NNC0650-0013 will be administered subcutaneously or intravenously.
DRUGPlacebo
Subcutaneous administration.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Male. * Age 18-55 years (both inclusive) at the time of signing the informed consent. * Body mass index between 24.0 and 29.9 kilogram per meter square (kg/m\^2) (both inclusive) at screening. * Considered to be otherwise healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Exclusion criteria
* Any disorder, unwillingness or inability, which, in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol. * Glycated haemoglobin (HbA1c) greater than or equal to 6.5 percent (48 millimoles per mole (mmol/mol)) at screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| S.C. Cohort: Number of treatment emergent adverse events (TEAEs) | From time of dosing (day 1) until completion of the follow-up visit (day 75) | Measured as number of events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| S.C. Cohort: AUC0-∞,0188,SD: Area under the NNC0519-0188 plasma concentration time curve from time 0 to infinity after a single dose | From pre-dose (day 1) until completion of the follow up visit (day 75) | Measured as hours nanomoles per liter (h\*nmol/L). |
| S.C. Cohort: Cmax,0188,SD: Maximum plasma concentration of NNC0519-0188 after a single dose | From pre-dose (day 1) until completion of the follow-up visit (day 75) | Measured as nanomoles per liter (nmol/L). |
| S.C. Cohort: AUC0-∞,0013,SD: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose | From pre-dose (day 1) until completion of the follow-up visit (day 75) | Measured as h\*nmol/L. |
| S.C. Cohort: Cmax,0013,SD: Maximum observed plasma concentration of NNC0650-0013 after a single dose | From pre-dose (day 1) until completion of the follow-up visit (day 75) | Measured as nanomoles per liter (nmol/L). |
| S.C. Cohort: AUC0-∞,0031,SD: Area under the NNC0650-0031plasma concentration time curve from time 0 to infinity after a single dose | From pre-dose (day 1) until completion of the follow-up visit (day 75) | Measured as h\*nmol/L. |
| S.C. Cohort: Cmax,0031,SD: Maximum observed plasma concentration of NNC0650-0031 after a single dose | From pre-dose (day 1) until completion of the follow-up visit (day 75) | Measured as nanomoles per liter (nmol/L). |
| I.V. Cohort: AUC0-∞,0188,SD: Area under the NNC0519-0188 plasma concentration-time curve from time 0 to infinity after a single dose | From pre-dose (day 1) until completion of the follow-up visit (day 75) | Measured as h\*nmol/L. |
| I.V. Cohort: AUC0-∞,0013,SD: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose | From pre-dose (day 1) until completion of the follow-up visit (day 75) | Measured as h\*nmol/L. |
| S.C. and I.V. Cohort: AUC0-∞,0013,SD/dose: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose divided by the dose administered | From pre-dose (day1) until completion of the follow-up visit (day 75) | Measured as hours nanomoles per milligram (h\*nmol/mg). |
| I.V. Cohort: AUC0-∞,0031,SD: Area under the NNC0650-0031 plasma concentration-time curve from time 0 to infinity after a single dose | From pre-dose (day 1) until completion of the follow-up visit (day 75) | Measured as h\*nmol/L. |
Countries
Germany
Outcome results
None listed