A Study to See How Safe a New Medicine (NNC0705-0002) is in Healthy People
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorNovo Nordisk A/S
About this trial
This study is testing NNC0705-0002, a new medicine that is being developed for conditions where inflammation may contribute to heart and metabolic health problems. The purpose of this study is to assess the safety, tolerability, pharmacokinetics, target engagement, and metabolism of NNC0705-0002 after single and multiple doses in healthy adults. NNC0705-0002 or a placebo (a substance that looks like the study medicine but contains no active medicine), and the treatment they receive may be chosen by chance. NNC0705-0002 is a new medicine that is not yet approved for doctors to prescribe. Depending on the part of the study, participation may last for up to about 7 weeks, including screening, treatment, and follow-up visits.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Men or women of non-childbearing potential.
Age 18-55 years (both inclusive) at the time of signing the informed consent.
Body mass index (BMI) between 18.5 to 29.9 kilogram per square metre (kg/m²) (both inclusive) at screening.
Body weight: greater than or equal to (≥) 50.0 kg at screening.
Disqualifiers
Known or suspected hypersensitivity to study intervention(s) or related products.
Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
Any of the below laboratory safety parameters at screening outside normal range, see designated reference range documents for specific values.
Alanine aminotransferase (ALT) greater than (>) upper limit of normal (ULN)
Trial design
Design model
Parallel
Treatments tested in this trial
NNC0705-0002
DrugParticipants will receive oral capsule of NNC0705-0002.
Placebo
DrugParticipants will receive oral capsule of placebo matched to NNC0705-0002.
Treatment groups
112 Participants
are divided into 2 treatment groupsGroup A: NNC0705-0002Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of treatment emergent adverse events (TEAEs)
Measured as number of events.
Time frame
From time of dosing (day 1) to day 72
Number of TEAEs
Measured as number of events.
Time frame
From time of dosing (day 1) to day 133
AUC0-t, SD; the area under the NNC0705- 0002 plasma concentration-time curve from time 0 to last measurable plasma concentration after a single dose
Measured as hour micromolar (h\*μM).
Time frame
From pre-dose (day 1 or day 10) to day 6 or day 154
Total recovery of administered radiolabelled NNC0705- 0002-related material (sum urine and faeces)
Measured as percentage (%) of dose.
Time frame
From time of dosing (day 1) to no later than day 21Secondary outcomes
1
AUC0-∞, SD; the area under the NNC0705- 0002 plasma concentration-time curve from time 0 to infinity after a single dose
Measured as h\*μM.
Time frame
From pre-dose (day 1) to day 72
Cmax, SD; the maximum observed plasma concentration of NNC0705-0002 after a single dose
Measured as micromolar (μM).
Time frame
From pre-dose (day 1) to day 73
AUCtau, MD; the area under the NNC0705- 0002 plasma concentration-time curve from time 0 to tau after the last dose
Measured as h\*μM.
Time frame
From pre-dose (day 7) to tau after last dose (day 8)4
Cmax, MD; the maximum observed plasma concentration of NNC0705-0002 after last dose
Measured as μM.
Time frame
From pre-dose (day 7) to day 13Sponsors and contacts
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Source ClinicalTrials.gov