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) |
|