Cardiometabolic Diseases, Healthy Volunteers
Conditions
Brief summary
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.
Interventions
DRUGNNC0705-0002
Participants will receive oral capsule of NNC0705-0002.
DRUGPlacebo
Participants will receive oral capsule of placebo matched to NNC0705-0002.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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/m\^2) (both inclusive) at screening. * Body weight: greater than or equal to (≥) 50.0 kg at screening. * Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Exclusion criteria
* 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) * Aspartate aminotransferase (AST) \>ULN * Total bilirubin (TBL) \>ULN * Creatinine \>ULN * International normalised ratio (INR) \>ULN * High-sensitivity C-reactive protein (hsCRP) greater than (\>)5 milligram per liter (mg/L) (males) and \>8 mg/L (females) * Use of prescription medicinal products or vaccines within 14 days before dosing and/or non-prescription medicinal products within 7 days before dosing. Exceptions are: Topical medications not reaching systemic circulation; less than once per week of over-the-counter acetaminophen/paracetamol and/or nonsteroidal anti-inflammatory drugs at their labelled doses for mild pain; vitamins at their labelled doses.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of treatment emergent adverse events (TEAEs) | From time of dosing (day 1) to day 7 | Measured as number of events. |
| Number of TEAEs | From time of dosing (day 1) to day 13 | Measured as number of events. |
| 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 | From pre-dose (day 1 or day 10) to day 6 or day 15 | Measured as hour micromolar (h\*μM). |
| Total recovery of administered radiolabelled NNC0705- 0002-related material (sum urine and faeces) | From time of dosing (day 1) to no later than day 21 | Measured as percentage (%) of dose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-∞, SD; the area under the NNC0705- 0002 plasma concentration-time curve from time 0 to infinity after a single dose | From pre-dose (day 1) to day 7 | Measured as h\*μM. |
| Cmax, SD; the maximum observed plasma concentration of NNC0705-0002 after a single dose | From pre-dose (day 1) to day 7 | Measured as micromolar (μM). |
| AUCtau, MD; the area under the NNC0705- 0002 plasma concentration-time curve from time 0 to tau after the last dose | From pre-dose (day 7) to tau after last dose (day 8) | Measured as h\*μM. |
| Cmax, MD; the maximum observed plasma concentration of NNC0705-0002 after last dose | From pre-dose (day 7) to day 13 | Measured as μM. |
| Dose-normalised AUC0-∞, SD; the area under the NNC0705-0002 or radiolabelled NNC0705-0002-related material total radioactivity (TRA) plasma concentration-time curve from time 0 to infinity after a single dose divided by dose | From pre-dose (day 1) to day 17 | Measured as hour micromolar per milligram (h\*μM/mg). |
| Total amount of radiolabelled NNC0705-0002- related material excreted in urine | From pre-dose (day 1) to day 6 | Measured as % of dose. |
| Total amount of radiolabelled NNC0705-0002- related material excreted in faeces | From pre-dose (day 1) to day 6 | Measured as % of dose. |
| AUC0-∞,14C,SD; area under the plasma concentration-time curve of radiolabelled NNC0705-0002-related material (TRA) from time 0 to infinity after a single dose | From pre-dose (day 1) to day 9 | Measured as hundreds of nanomoles per litre (h\*nmol/L). |
| Number of TEAEs | From time of dosing (day 1) to day 17 | Measured as number of events. |
| Cmax,14C,SD: maximum observed plasma concentration of radiolabelled NNC0705-0002- related material (TRA) after a single dose | From pre-dose (day 1) to no later than day 21 | Measured as nanomole per litre (nmol/L). |
| AUC0-∞,SD; area under the plasma concentration-time curve of NNC0705- 0002 from time 0 to infinity after a single dose | From pre-dose (day 1) to day 5 | Measured as h\*nmol/L. |
| Cmax,SD: maximum observed plasma concentration of NNC0705-0002 after a single dose | From pre-dose (day 1) to day 5 | Measured as nmol/L. |
Countries
Netherlands
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed