Clinical trial NCT05521256: A Research Study of a New Medicine NNC0113-6856 in Healthy Males
Official title: A First Human Dose Study Investigating Safety, Tolerability, and Pharmacokinetics of Oral Single Doses of NNC0113-6856 in Healthy Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Type 2 Diabetes
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2022-08-30
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Number of adverse events
timeFrame: From time of dosing (day 1) until completion of the follow-up visit (Day 42)
Secondary outcomes:
measure: 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
timeFrame: From pre-dose (day 1) to completion of follow-up visit (Day 42)
measure: For oral cohorts- AUC0-infinity (∞),sema,SD: Area under the semaglutide plasma concentration-time curve from time 0 to infinity after a single dose
timeFrame: From pre-dose (day 1) to completion of follow-up visit (Day 42)
measure: For oral cohorts- Cmax,sema,SD: Maximum observed plasma concentration of semaglutide after a single dose
timeFrame: From pre-dose (day 1) to completion of follow-up visit (day 42)
measure: For oral cohorts- tmax,sema,SD: Time to maximum observed concentration of semaglutide after a single dose
timeFrame: From pre-dose (day 1) to completion of follow-up visit (day 42)
measure: For oral cohorts- t½,sema,SD: Terminal half-life of semaglutide after a single dose
timeFrame: From pre-dose (day 1) to completion of follow-up visit (day 42)
measure: 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
timeFrame: From pre-dose (day 1) to completion of visit 5 (day 22)
measure: For oral cohorts- AUC0-∞,6856,SD: Area under the NNC0113-6856 plasma concentration-time curve from time 0 to infinity after a single dose
timeFrame: From pre-dose (day 1) to completion of visit 5 (day 22)
measure: For oral cohorts- Cmax,6856,SD: Maximum observed plasma concentration of NNC0113-6856 after a single dose
timeFrame: From pre-dose (day 1) to completion of visit 5 (day 22)
measure: For oral cohorts- tmax,6856,SD: Time to maximum observed concentration of NNC0113-6856 after a single dose
timeFrame: From pre-dose (day 1) to completion of visit 5 (Day 22)
measure: For oral cohorts- t½,6856,SD: Terminal half-life of NNC0113-6856 after a single dose
timeFrame: From pre-dose (day 1) to completion of visit 5 (Day 22)
measure: 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
timeFrame: From pre-dose (day 1) to completion of visit 5 (Day 22)
measure: For oral cohorts- AUC0-∞,4768,SD: Area under the NNC0113-4768 plasma concentration-time curve from time 0 to infinity after a single dose
timeFrame: From pre-dose (day 1) to completion of visit 5 (Day 22)
measure: For oral cohorts- Cmax,4768,SD: Maximum observed plasma concentration of NNC0113-4768 after a single dose
timeFrame: From pre-dose (day 1) to completion of visit 5 (Day 22)
measure: For oral cohorts- tmax,4768,SD: Time to maximum observed concentration of NNC0113-4768 after a single dose
timeFrame: From pre-dose (day 1) to completion of visit 5 (Day 22)
measure: For oral cohorts- t½,4768,SD: Terminal half-life of NNC0113-4768 after a single dose
timeFrame: From pre-dose (day 1) to completion of visit 5 (Day 22)
measure: 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
timeFrame: From pre-dose (day 1) to completion of follow-up visit (day 42)
measure: For i.v. cohort- t½,sema,SD: Terminal half-life of semaglutide after a single dose
timeFrame: From pre-dose (day 1) to completion of follow-up visit (day 42)
measure: For i.v. cohort- Cmax,sema,SD: Maximum observed plasma concentration of semaglutide after a single dose
timeFrame: From pre-dose (day 1) to completion of follow-up visit (day 42)
measure: 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
timeFrame: From pre-dose (day 1) to completion of visit 5 (day 22)
measure: For i.v. cohort- t½,6856,SD: Terminal half-life of NNC0113-6856 after a single dose
timeFrame: From pre-dose (day 1) to completion of visit 5 (day 22)
measure: For i.v. cohort- CL6856,SD: Total plasma clearance of NNC0113-6856 after a single dose
timeFrame: From pre-dose (day 1) to completion of visit 5 (Day 22)
measure: For i.v. cohort- Vz6856,SD: Apparent volume of distribution of NNC0113-6856 after a single dose based on plasma concentration values
timeFrame: From pre-dose (day 1) to completion of visit 5 (Day 22)
measure: For i.v. cohort- MRT6856,SD: Mean residence time for NNC0113-6856 after a single dose
timeFrame: From pre-dose (day 1) to completion of visit 5 (Day 22)
measure: 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
timeFrame: From pre-dose (day 1) to completion of visit 5 (Day 22)
measure: For i.v. cohort- t½,4768,SD: Terminal half-life of NNC0113-4768 after a single dose
timeFrame: From pre-dose (day 1) to completion of visit 5 (Day 22)
measure: 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
timeFrame: From pre-dose (day 1) to completion of visit 5 (Day 22)
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Profil Institut für Stoffwechselforschung GmbH
state: North Rhine-Westphalia
city: Neuss
country: Germany
facility: Profil Institut für Stoffwechselforschung GmbH
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency dept. 2834
role: STUDY_DIRECTOR
References: