Healthy Participants
Conditions
Brief summary
NNC0113-6856 is a new medicine which may help participants with type 2 diabetes to improve blood sugar control. NNC0113-6856 is slowly converted in the body to semaglutide, a substance similar to a hormone (signaling substance) in the body. The main purpose of this study will be to evaluate the safety of different strengths of NNC0113-6856 when given as multiple administrations, and the amount of NNC0113-6856 in the blood will be measured as well as the amount of specific parts (including semaglutide). Participants will either get multiple doses of the new medicine NNC0113-6856 or multiple doses of placebo (a dummy medicine that looks like the new medicine but is without any active ingredient). Whether participants get the new medicine or placebo is decided by chance. The duration of the study could last up to 25 weeks.
Interventions
DRUGNNC0113-6856
NNC0113-6856 will be administered as oral tablets.
DRUGPlacebo
NNC0113-6856 matching placebo will be administered as oral tablets.
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
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female. * Age 18-55 years (both inclusive) at the time of signing the informed consent. * Body mass index (BMI) between 21.0 and 29.9 kilograms per meter square (kg/m\^2) (both inclusive) at screening. Additional for healthy Japanese participants: * First generation Japanese (Japanese born participants).
Exclusion criteria
* HbA1c greater than or equal to (≥) 6.5 percent (%) (48 millimoles per mole \[mmol/mol\]) at screening. * 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: 1. Alanine Aminotransferase (ALT) greater than (\>) upper normal limit (UNL) +10% 2. Aspartate aminotransferase (AST) \> UNL+20% 3. Total bilirubin \> UNL+20% 4. Creatinine \> UNL+10% 5. International normalised ratio (INR) \> UNL
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events (AEs) | From time of first dosing (day 1) until completion of the follow-up visit (day 148) | Measured as number of events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1 (MAD): Cmax,sema,SS: maximum observed plasma concentration of semaglutide at steady state | From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106 | Measured in nanomoles per liter(nmol/L). |
| Part 1 (MAD): AUCτ,6856,SS: area under the NNC0113-6856 plasma concentration-time curve during a dosing interval τ at steady state | From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106 | Measured in h\*nmol/L. |
| Part 1 (MAD): Cmax,6856,SS: maximum observed plasma concentration of NNC0113-6856 at steady state | From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106 | Measured in nmol/L. |
| Part 1 (MAD): AUCτ,4768,SS: area under the NNC0113-4768 plasma concentration-time curve during a dosing interval τ at steady state | From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106 | Measured in h\*nmol/L. |
| Part 1 (MAD): Cmax,4768,SS: maximum observed plasma concentration of NNC0113-4768 at steady state | From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106 | Measured in nmol/L. |
| Part 2 Dosing condition (DC): AUCτ,sema,SS: area under the semaglutide plasma concentration-time curve during a dosing interval τ at steady state | From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106 | Measured in h\*nmol/L. |
| Part 2 (DC): Cmax,sema,SS: maximum observed plasma concentration of semaglutide at steady state | From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106 | Measured in nmol/L. |
| Part 2 (DC): AUCτ,6856,SS: area under the NNC0113-6856 plasma concentration-time curve during a dosing interval τ at steady state | From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106 | Measured in h\*nmol/L. |
| Part 1 Multiple ascending dose (MAD): AUCτ,sema,SS: area under the semaglutide plasma concentration-time curve during a dosing interval τ at steady state | From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106 | Measured in hours\*nanomoles per liter (h\*nmol/L). |
| Part 2 (DC): AUCτ,4768,SS: area under the NNC0113-4768 plasma concentration-time curve during a dosing interval τ at steady state | From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106 | Measured in h\*nmol/L. |
| Part 2 (DC): Cmax,4768,SS: maximum observed plasma concentration of NNC0113-4768 at steady state | From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106 | Measured in nmol/L. |
| Part 3 Japanese (JP): AUCτ,sema,SS: area under the semaglutide plasma concentration-time curve during a dosing interval τ at steady state | From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106 | Measured in h\*nmol/L. |
| Part 3 (JP): Cmax,sema,SS: maximum observed plasma concentration of semaglutide at steady state | From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106 | Measured in nmol/L. |
| Part 3 (JP): AUCτ,6856,SS: area under the NNC0113-6856 plasma concentration-time curve during a dosing interval τ at steady state | From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106 | Measured in h\*nmol/L. |
| Part 3 (JP): Cmax,6856,SS: maximum observed plasma concentration of NNC0113-6856 at steady state | From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106 | Measured in nmol/L. |
| Part 3 (JP): AUCτ,4768,SS: area under the NNC0113-4768 plasma concentration-time curve during a dosing interval τ at steady state | From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106 | Measured in h\*nmol/L. |
| Part 3 (JP): Cmax,4768,SS: maximum observed plasma concentration of NNC0113-4768 at steady state | From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106 | Measured in nmol/L. |
| Part 2 (DC): Cmax,6856,SS: maximum observed plasma concentration of NNC0113-6856 at steady state | From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106 | Measured in nmol/L. |
Countries
Germany
Outcome results
None listed