Clinical trial NCT06069895: Investigation of Safety, Tolerability and Pharmacokinetics of Multiple Doses of NNC0113-6856 in Healthy Participants, Including a Subset of Healthy Japanese Participants
Official title: Investigation of Safety, Tolerability and Pharmacokinetics of Multiple Doses of NNC0113-6856 in Healthy Participants, Including a Subset of Healthy Japanese Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2023-10-06
Enrollment: 170
Sex: ALL
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: NNC0113-6856 is a new medicine which may help participants with type 2 diabetes to improve blood sugar control. NNC0113-6856 is slowly converted in the body to semaglutide, a substance similar to a hormone (signaling substance) in the body. The main purpose of this study will be to evaluate the safety of different strengths of NNC0113-6856 when given as multiple administrations, and the amount of NNC0113-6856 in the blood will be measured as well as the amount of specific parts (including semaglutide). Participants will either get multiple doses of the new medicine NNC0113-6856 or multiple doses of placebo (a "dummy" medicine that looks like the new medicine but is without any active ingredient). Whether participants get the new medicine or placebo is decided by chance. The duration of the study could last up to 25 weeks.


Eligibility criteria: Inclusion Criteria:

* Male or female.
* Age 18-55 years (both inclusive) at the time of signing the informed consent.
* Body mass index (BMI) between 21.0 and 29.9 kilograms per meter square (kg/m\^2) (both inclusive) at screening.

Additional for healthy Japanese participants:

* First generation Japanese (Japanese born participants).

Exclusion Criteria:

* HbA1c greater than or equal to (≥) 6.5 percent (%) (48 millimoles per mole \[mmol/mol\]) at screening.
* 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:

  1. Alanine Aminotransferase (ALT) greater than (\>) upper normal limit (UNL) +10%
  2. Aspartate aminotransferase (AST) \> UNL+20%
  3. Total bilirubin \> UNL+20%
  4. Creatinine \> UNL+10%
  5. International normalised ratio (INR) \> UNL

Primary outcomes:
measure: Number of adverse events (AEs)
timeFrame: From time of first dosing (day 1) until completion of the follow-up visit (day 148)
Secondary outcomes:
measure: Part 1 Multiple ascending dose (MAD): AUCτ,sema,SS: area under the semaglutide plasma concentration-time curve during a dosing interval τ at steady state
timeFrame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
measure: Part 1 (MAD): Cmax,sema,SS: maximum observed plasma concentration of semaglutide at steady state
timeFrame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
measure: Part 1 (MAD): AUCτ,6856,SS: area under the NNC0113-6856 plasma concentration-time curve during a dosing interval τ at steady state
timeFrame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
measure: Part 1 (MAD): Cmax,6856,SS: maximum observed plasma concentration of NNC0113-6856 at steady state
timeFrame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
measure: Part 1 (MAD): AUCτ,4768,SS: area under the NNC0113-4768 plasma concentration-time curve during a dosing interval τ at steady state
timeFrame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
measure: Part 1 (MAD): Cmax,4768,SS: maximum observed plasma concentration of NNC0113-4768 at steady state
timeFrame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
measure: Part 2 Dosing condition (DC): AUCτ,sema,SS: area under the semaglutide plasma concentration-time curve during a dosing interval τ at steady state
timeFrame: From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106
measure: Part 2 (DC): Cmax,sema,SS: maximum observed plasma concentration of semaglutide at steady state
timeFrame: From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106
measure: Part 2 (DC): AUCτ,6856,SS: area under the NNC0113-6856 plasma concentration-time curve during a dosing interval τ at steady state
timeFrame: From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106
measure: Part 2 (DC): Cmax,6856,SS: maximum observed plasma concentration of NNC0113-6856 at steady state
timeFrame: From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106
measure: Part 2 (DC): AUCτ,4768,SS: area under the NNC0113-4768 plasma concentration-time curve during a dosing interval τ at steady state
timeFrame: From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106
measure: Part 2 (DC): Cmax,4768,SS: maximum observed plasma concentration of NNC0113-4768 at steady state
timeFrame: From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106
measure: Part 3 Japanese (JP): AUCτ,sema,SS: area under the semaglutide plasma concentration-time curve during a dosing interval τ at steady state
timeFrame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
measure: Part 3 (JP): Cmax,sema,SS: maximum observed plasma concentration of semaglutide at steady state
timeFrame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
measure: Part 3 (JP): AUCτ,6856,SS: area under the NNC0113-6856 plasma concentration-time curve during a dosing interval τ at steady state
timeFrame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
measure: Part 3 (JP): Cmax,6856,SS: maximum observed plasma concentration of NNC0113-6856 at steady state
timeFrame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
measure: Part 3 (JP): AUCτ,4768,SS: area under the NNC0113-4768 plasma concentration-time curve during a dosing interval τ at steady state
timeFrame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
measure: Part 3 (JP): Cmax,4768,SS: maximum observed plasma concentration of NNC0113-4768 at steady state
timeFrame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Other outcomes:
Locations:
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: