A Study to See How Safe a New Medicine (NNC0705-0002) is in Healthy People

Phase 1Not Yet RecruitingNCT07797855

Novo Nordisk A/S112 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

112

Conditions

Healthy Volunteers Cardiometabolic Diseases

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Number of treatment emergent adverse events (TEAEs)

Measured as number of events.

Time frame: From time of dosing (day 1) to day 7

Number of TEAEs

Measured as number of events.

Time frame: From time of dosing (day 1) to day 13

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 15

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 21

Secondary Outcomes

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 7

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 7

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)

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 13

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 or day 10) to day 6 or day 15

Cmax, SD; the maximum observed plasma concentration of NNC0705-0002 after a single dose

Measured as μM.

Time frame: From pre-dose (day 1 or day 10) to day 6 or day 15

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

Measured as hour micromolar per milligram (h\*μM/mg).

Time frame: From pre-dose (day 1) to day 17

Total amount of radiolabelled NNC0705-0002- related material excreted in urine

Measured as % of dose.

Time frame: From pre-dose (day 1) to day 6

Total amount of radiolabelled NNC0705-0002- related material excreted in faeces

Measured as % of dose.

Time frame: From pre-dose (day 1) to day 6

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

Measured as hundreds of nanomoles per litre (h\*nmol/L).

Time frame: From pre-dose (day 1) to day 9

Number of TEAEs

Measured as number of events.

Time frame: From time of dosing (day 1) to day 17

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

Measured as h\*nmol/L.

Time frame: From pre-dose (day 1) to no later than day 21

Cmax,14C,SD: maximum observed plasma concentration of radiolabelled NNC0705-0002- related material (TRA) after a single dose

Measured as nanomole per litre (nmol/L).

Time frame: From pre-dose (day 1) to no later than day 21

AUC0-∞,SD; area under the plasma concentration-time curve of NNC0705- 0002 from time 0 to infinity after a single dose

Measured as h\*nmol/L.

Time frame: From pre-dose (day 1) to day 5

Cmax,SD: maximum observed plasma concentration of NNC0705-0002 after a single dose

Measured as nmol/L.

Time frame: From pre-dose (day 1) to day 5

Number of TEAEs

Measured as number of events.

Time frame: From time of dosing (day 1) to day 23

A Study to See How Safe a New Medicine (NNC0705-0002) is in Healthy People

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts