A Research Study of a New Medicine NNC0113-6856 in Healthy Males

Phase 1

Completed

• Conditions: Healthy Volunteers; Type 2 Diabetes
• Interventions: Drug: NNC0113-6856; Drug: Placebo

• Registration Number: NCT05521256
• Lead Sponsor: Novo Nordisk A/S

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-26
• Study First Submitted: 2022-08-27
• Study First Submitted QC: 2022-08-27
• Study First Posted: 2022-08-30
• Primary Completion: 2023-03-27
• Study Completion: 2023-03-27
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
NNC0113-6856 (Oral Cohort)	NNC0113-6856	Participants will receive single oral dose of NNC0113-6856 tablets in dose escalated manner.
Placebo	Placebo	Participants will receive single oral dose of placebo (NNC0113-6856) tablets in dose escalated manner.
NNC0113-6856 (i.v. Cohort)	NNC0113-6856	Participants will receive single dose of 1.5 milligrams (mg) NNC0113-6856 intravenously (i.v.).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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-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- 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- 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-∞,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- 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- 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- 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).
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).

Trial Locations

Locations (1)

Profil Institut für Stoffwechselforschung GmbH; 🇩🇪 Neuss, Germany