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

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06069895
• Other study ID #: NN9904-5008
• Secondary ID: U1111-1284-5743
• Status: Recruiting
• Phase: Phase 1
• Start date: October 4, 2023
• Est. completion date: June 6, 2025

Study information

• Verified date: January 2024
• Source: Novo Nordisk A/S
• Contact: Novo Nordisk
• Phone: (+1) 866-867-7178
• Email: clinicaltrials[@]novonordisk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: June 6, 2025
• Est. primary completion date: June 6, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• NNC0113-6856
NNC0113-6856 will be administered as oral tablets.
• Placebo
NNC0113-6856 matching placebo will be administered as oral tablets.

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Part 1 Multiple ascending dose (MAD): AUCt,sema,SS: area under the semaglutide plasma concentration-time curve during a dosing interval t 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
Secondary	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
Secondary	Part 1 (MAD): AUCt,6856,SS: area under the NNC0113-6856 plasma concentration-time curve during a dosing interval t 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
Secondary	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
Secondary	Part 1 (MAD): AUCt,4768,SS: area under the NNC0113-4768 plasma concentration-time curve during a dosing interval t 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
Secondary	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
Secondary	Part 2 Dosing condition (DC): AUCt,sema,SS: area under the semaglutide plasma concentration-time curve during a dosing interval t 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
Secondary	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
Secondary	Part 2 (DC): AUCt,6856,SS: area under the NNC0113-6856 plasma concentration-time curve during a dosing interval t 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
Secondary	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
Secondary	Part 2 (DC): AUCt,4768,SS: area under the NNC0113-4768 plasma concentration-time curve during a dosing interval t 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
Secondary	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
Secondary	Part 3 Japanese (JP): AUCt,sema,SS: area under the semaglutide plasma concentration-time curve during a dosing interval t 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
Secondary	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
Secondary	Part 3 (JP): AUCt,6856,SS: area under the NNC0113-6856 plasma concentration-time curve during a dosing interval t 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
Secondary	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
Secondary	Part 3 (JP): AUCt,4768,SS: area under the NNC0113-4768 plasma concentration-time curve during a dosing interval t 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
Secondary	Part 3 (JP): 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