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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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