The study is testing a new study medicine (called NNC0705-0001), as a potential medicine to treat chronic systemic inflammation, which is known for increasing the risk of developing cardiometabolic diseases. The aim of this study is to see if the study medicine is safe, how it works in our body, and what our body does to the study medicine. The participant will either get NNC0705-0001 or placebo (a "dummy medicine" without the active ingredient). Which treatment the participant gets is decided by chance. The study consists of 3 parts: PART A - single ascending dose (SAD); PART B - multiple ascending doses (MAD) and PART C - food effect (FE) on the pharmacokinetic (PK) properties of NNC0705-0001 and will last about 35 days (PART A) and 41 days (PART B and C).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
116
NNC0705-0001 will be administered orally.
Placebo matching NNC0705-0001 will be administered orally.
ICON - location Groningen
Groningen, Netherlands
PART A: Number of treatment emergent adverse events (TEAE)
Measured in number of events.
Time frame: From time of dosing (day 1) to end of study (day 7)
PART B: Number of TEAEs
Measured in number of events.
Time frame: From time of dosing (day 1) to end of study (day 13)
AUC, SD; the area under the NNC0705-0001 plasma concentration-time curve after a single dose
Measured in Hour x Micromole (hr×μM).
Time frame: From pre-dose (day 1 or day 8) to day 2 or day 9
PART A: AUC0-t, SD; the area under the NN0705-0001 plasma concentration-time curve from time 0 to last measurable plasma concentration after a single dose
Measured in hr×μM.
Time frame: From pre-dose (day 1) to day 5
PART A: AUC0-∞, SD; the area under the NNC0705-0001 plasma concentration-time curve from time 0 to infinity after a single dose
Measured in hr×μM.
Time frame: From pre-dose (day 1) to day 5
PART A: Cmax, SD; the maximum plasma concentration of NNC0705-0001 after a single dose
Measured in micromole (μM).
Time frame: From pre-dose (day 1) to day 5
PART B: AUCtau, MD; the area under the NN0705-0001 plasma concentration-time curve from time 0 to tau after the last dose
Measured in hr×μM.
Time frame: From pre-dose (day 7) to end of study (day 13)
PART B: Cmax, MD; the maximum plasma concentration of NNC0705-0001 after last dose
Measured in μM.
Time frame: From pre-dose (day 7) to end of study (day 13)
PART C: Cmax, SD; the maximum plasma concentration of NNC0705-0001 after a single dose
Measured in μM.
Time frame: From pre-dose (day 1 or day 8) to day 2 or day 9
PART C: Number of TEAEs
Measured in number of events.
Time frame: From time of dosing (day 1) to end of study (day 12)
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