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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1270-0813 | Other Identifier | World Health Organization (WHO) | |
| 2021-005397-26 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0113-6856 (Oral Cohort) | Experimental | Participants will receive single oral dose of NNC0113-6856 tablets in dose escalated manner. |
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| Placebo | Placebo Comparator | Participants will receive single oral dose of placebo (NNC0113-6856) tablets in dose escalated manner. |
|
| NNC0113-6856 (i.v. Cohort) | Experimental | Participants will receive single dose of 1.5 milligrams (mg) NNC0113-6856 intravenously (i.v.). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0113-6856 | Drug | Participants will receive NN0113-6856 orally or intravenously. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | Measured as number of events. | From time of dosing (day 1) until completion of the follow-up visit (Day 42) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
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:
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:
Precence or history of hepatitis
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency dept. 2834 | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institut für Stoffwechselforschung GmbH | Neuss | North Rhine-Westphalia | 41460 | Germany | ||
| Profil GmbH & Co. KG |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Drug | Participants will receive matching placebo of NNC0113-6856 for each of the oral cohorts. |
|
| For oral cohorts- AUC0-infinity (∞),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) |
| 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) |
| 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) |
| 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) |
| 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) |
| For oral cohorts- AUC0-∞,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) |
| 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) |
| 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) |
| 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) |
| 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) |
| For oral cohorts- AUC0-∞,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) |
| 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) |
| 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) |
| 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) |
| 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 | Measured in hours*nanomoles per liter (h*nmol/L). | From pre-dose (day 1) to completion of follow-up visit (day 42) |
| 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) |
| 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) |
| 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 | Measured as hours*nanomoles per liter (h*nmol/L) | From pre-dose (day 1) to completion of visit 5 (day 22) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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 | Measured in hours*nanomoles per liter (h*nmol/L). | From pre-dose (day 1) to completion of visit 5 (Day 22) |
| 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) |
| 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 | Measured in hours*nanomoles per liter per milligram (h*nmol/L/mg). | From pre-dose (day 1) to completion of visit 5 (Day 22) |
| Mainz |
| 55116 |
| Germany |
| Profil Institut für Stoffwechselforschung GmbH | Neuss | 41460 | Germany |
| D004700 | Endocrine System Diseases |