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

Healthy Volunteers Clinical Trial

Official title:

A First Human Dose Study Investigating Safety, Tolerability, and Pharmacokinetics of Oral Single Doses of NNC0113-6856 in Healthy Male Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05521256
• Other study ID #: NN9904-4825
• Secondary ID: U1111-1270-08132
• Status: Completed
• Phase: Phase 1
• Start date: August 26, 2022
• Est. completion date: March 27, 2023

Study information

• Verified date: July 2023
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 27, 2023
• Est. primary completion date: March 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers
• Type 2 Diabetes

Intervention

Drug:
• NNC0113-6856
Participants will receive NN0113-6856 orally or intravenously.
• Placebo
Participants will receive matching placebo of NNC0113-6856 for each of the oral cohorts.

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Neuss	North Rhine-Westphalia
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	Measured as number of events.	From time of dosing (day 1) until completion of the follow-up visit (Day 42)
Secondary	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	Measured in hours*nanomoles per liter (h*nmol/L).	From pre-dose (day 1) to completion of follow-up visit (Day 42)
Secondary	For oral cohorts- AUC0-infinity (8),sema,SD: Area under the semaglutide plasma concentration-time curve from time 0 to infinity after a single dose	Measured in hours*nanomoles per liter (h*nmol/L).	From pre-dose (day 1) to completion of follow-up visit (Day 42)
Secondary	For oral cohorts- Cmax,sema,SD: Maximum observed plasma concentration of semaglutide after a single dose	Measured in nanomoles per liter (nmol/L).	From pre-dose (day 1) to completion of follow-up visit (day 42)
Secondary	For oral cohorts- tmax,sema,SD: Time to maximum observed concentration of semaglutide after a single dose	Measured in hours (h).	From pre-dose (day 1) to completion of follow-up visit (day 42)
Secondary	For oral cohorts- t½,sema,SD: Terminal half-life of semaglutide after a single dose	Measured in hours (h).	From pre-dose (day 1) to completion of follow-up visit (day 42)
Secondary	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	Measured in hours*nanomoles per liter (h*nmol/L).	From pre-dose (day 1) to completion of visit 5 (day 22)
Secondary	For oral cohorts- AUC0-8,6856,SD: Area under the NNC0113-6856 plasma concentration-time curve from time 0 to infinity after a single dose	Measured as hours*nanomoles per liter (h*nmol/L).	From pre-dose (day 1) to completion of visit 5 (day 22)
Secondary	For oral cohorts- Cmax,6856,SD: Maximum observed plasma concentration of NNC0113-6856 after a single dose	Measured as nanomoles per liter (nmol/L).	From pre-dose (day 1) to completion of visit 5 (day 22)
Secondary	For oral cohorts- tmax,6856,SD: Time to maximum observed concentration of NNC0113-6856 after a single dose	Measured in hours (h).	From pre-dose (day 1) to completion of visit 5 (Day 22)
Secondary	For oral cohorts- t½,6856,SD: Terminal half-life of NNC0113-6856 after a single dose	Measured in hours (h).	From pre-dose (day 1) to completion of visit 5 (Day 22)
Secondary	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	Measured in hours*nanomoles per liter (h*nmol/L).	From pre-dose (day 1) to completion of visit 5 (Day 22)
Secondary	For oral cohorts- AUC0-8,4768,SD: Area under the NNC0113-4768 plasma concentration-time curve from time 0 to infinity after a single dose	Measured in hours*nanomoles per liter (h*nmol/L).	From pre-dose (day 1) to completion of visit 5 (Day 22)
Secondary	For oral cohorts- Cmax,4768,SD: Maximum observed plasma concentration of NNC0113-4768 after a single dose	Measured in nanomoles per liter (nmol/L).	From pre-dose (day 1) to completion of visit 5 (Day 22)
Secondary	For oral cohorts- tmax,4768,SD: Time to maximum observed concentration of NNC0113-4768 after a single dose	Measured in hours (h).	From pre-dose (day 1) to completion of visit 5 (Day 22)
Secondary	For oral cohorts- t½,4768,SD: Terminal half-life of NNC0113-4768 after a single dose	Measured in hours (h).	From pre-dose (day 1) to completion of visit 5 (Day 22)
Secondary	For intravenous (i.v.) cohort- AUC0-infinity (8),sema,SD: Area under the semaglutide plasma concentration-time curve from time 0 to infinity after a single dose	Measured in hours*nanomoles per liter (h*nmol/L).	From pre-dose (day 1) to completion of follow-up visit (day 42)
Secondary	For i.v. cohort- t½,sema,SD: Terminal half-life of semaglutide after a single dose	Measured in hours (h).	From pre-dose (day 1) to completion of follow-up visit (day 42)
Secondary	For i.v. cohort- Cmax,sema,SD: Maximum observed plasma concentration of semaglutide after a single dose	Measured in nanomoles per liter (nmol/L).	From pre-dose (day 1) to completion of follow-up visit (day 42)
Secondary	For i.v. cohort- AUC0-8,6856,SD: Area under the NNC0113-6856 plasma concentration-time curve from time 0 to infinity after a single dose	Measured as hours*nanomoles per liter (h*nmol/L)	From pre-dose (day 1) to completion of visit 5 (day 22)
Secondary	For i.v. cohort- t½,6856,SD: Terminal half-life of NNC0113-6856 after a single dose	Measured in hours (h).	From pre-dose (day 1) to completion of visit 5 (day 22)
Secondary	For i.v. cohort- CL6856,SD: Total plasma clearance of NNC0113-6856 after a single dose	Measured in liters per hour (L/h).	From pre-dose (day 1) to completion of visit 5 (Day 22)
Secondary	For i.v. cohort- Vz6856,SD: Apparent volume of distribution of NNC0113-6856 after a single dose based on plasma concentration values	Measured in liters (L).	From pre-dose (day 1) to completion of visit 5 (Day 22)
Secondary	For i.v. cohort- MRT6856,SD: Mean residence time for NNC0113-6856 after a single dose	Measured in hours (h).	From pre-dose (day 1) to completion of visit 5 (Day 22)
Secondary	For i.v. cohort- AUC0-infinity (8),4768,SD: Area under the NNC0113-4768 plasma concentration-time curve from time 0 to infinity after a single dose	Measured in hours*nanomoles per liter (h*nmol/L).	From pre-dose (day 1) to completion of visit 5 (Day 22)
Secondary	For i.v. cohort- t½,4768,SD: Terminal half-life of NNC0113-4768 after a single dose	Measured in hours (h).	From pre-dose (day 1) to completion of visit 5 (Day 22)
Secondary	For i.v. cohort and oral cohort- AUC0-8,6856,SD/dose: Area under the NNC0113-6856 plasma concentration-time curve from 0 to infinity after a single dose divided by the dose administered	Measured in hours*nanomoles per liter per milligram (h*nmol/L/mg).	From pre-dose (day 1) to completion of visit 5 (Day 22)