Investigation of Safety, Tolerability and Pharmacokinetics of Multiple Doses of NNC0113-6856 in Healthy Participants, Including a Subset of Healthy Japanese Participants

Study Overview
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Brief Summary
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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.

Official Title
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Investigation of Safety, Tolerability and Pharmacokinetics of Multiple Doses of NNC0113-6856 in Healthy Participants, Including a Subset of Healthy Japanese Participants

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: NNC0113-6856
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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: Alanine Aminotransferase (ALT) greater than (>) upper normal limit (UNL) +10% Aspartate aminotransferase (AST) > UNL+20% Total bilirubin > UNL+20% Creatinine > UNL+10% International normalised ratio (INR) > UNL

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NNC0113-6856<br>Participants will receive NNC0113-6856 oral tablets. | Drug: NNC0113-6856<br>* NNC0113-6856 will be administered as oral tablets.<br>|
| Experimental: Placebo<br>Participants will receive NNC0113-6856 matching placebo oral tablets. | Drug: Placebo<br>* NNC0113-6856 matching placebo will be administered as oral tablets.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events (AEs) | Measured as number of events. | From time of first dosing (day 1) until completion of the follow-up visit (day 148) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Measured in hours*nanomoles per liter (h*nmol/L). | From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106 | 
| Part 1 (MAD): Cmax,sema,SS: maximum observed plasma concentration of semaglutide at steady state | Measured in nanomoles per liter(nmol/L). | From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106 | 
| Part 1 (MAD): AUCτ,6856,SS: area under the NNC0113-6856 plasma concentration-time curve during a dosing interval τ at steady state | Measured in h*nmol/L. | From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106 | 
| Part 1 (MAD): Cmax,6856,SS: maximum observed plasma concentration of NNC0113-6856 at steady state | Measured in nmol/L. | From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106 | 
| Part 1 (MAD): AUCτ,4768,SS: area under the NNC0113-4768 plasma concentration-time curve during a dosing interval τ at steady state | Measured in h*nmol/L. | From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106 | 
| Part 1 (MAD): Cmax,4768,SS: maximum observed plasma concentration of NNC0113-4768 at steady state | Measured in nmol/L. | From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106 | 
| Part 2 Dosing condition (DC): AUCτ,sema,SS: area under the semaglutide plasma concentration-time curve during a dosing interval τ at steady state | Measured in h*nmol/L. | From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106 | 
| Part 2 (DC): Cmax,sema,SS: maximum observed plasma concentration of semaglutide at steady state | Measured in nmol/L. | From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106 | 
| Part 2 (DC): AUCτ,6856,SS: area under the NNC0113-6856 plasma concentration-time curve during a dosing interval τ at steady state | Measured in h*nmol/L. | From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106 | 
| Part 2 (DC): Cmax,6856,SS: maximum observed plasma concentration of NNC0113-6856 at steady state | Measured in nmol/L. | From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106 | 
| Part 2 (DC): AUCτ,4768,SS: area under the NNC0113-4768 plasma concentration-time curve during a dosing interval τ at steady state | Measured in h*nmol/L. | From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106 | 
| Part 2 (DC): Cmax,4768,SS: maximum observed plasma concentration of NNC0113-4768 at steady state | Measured in nmol/L. | From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106 | 
| Part 3 Japanese (JP): AUCτ,sema,SS: area under the semaglutide plasma concentration-time curve during a dosing interval τ at steady state | Measured in h*nmol/L. | From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106 | 
| Part 3 (JP): Cmax,sema,SS: maximum observed plasma concentration of semaglutide at steady state | Measured in nmol/L. | From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106 | 
| Part 3 (JP): AUCτ,6856,SS: area under the NNC0113-6856 plasma concentration-time curve during a dosing interval τ at steady state | Measured in h*nmol/L. | From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106 | 
| Part 3 (JP): Cmax,6856,SS: maximum observed plasma concentration of NNC0113-6856 at steady state | Measured in nmol/L. | From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106 | 
| Part 3 (JP): AUCτ,4768,SS: area under the NNC0113-6856 plasma concentration-time curve during a dosing interval τ at steady state | Measured in h*nmol/L. | From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106 | 
| Part 3 (JP): Cmax,4768,SS: maximum observed plasma concentration of NNC0113-6856 at steady state | Measured in nmol/L. | From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106 |