Chronic Kidney Disease, Healthy Volunteers
Conditions
Brief summary
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).
Interventions
DRUGNNC0705-0001
NNC0705-0001 will be administered orally.
DRUGPlacebo
Placebo matching NNC0705-0001 will be administered orally.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
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 meter square (kg/m\^2) (both inclusive) at screening. * Body weight: greater than or equal to (≥) 50 kilogram (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 (BIL) \> ULN; Creatinine \> ULN; International normalized ratio (INR) \> ULN; High-Sensitivity C-Reactive Protein (hsCRP) \> 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 paracetamol and/or acetylsalicylic acid at their labelled doses for mild pain; vitamins at their labelled doses.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC, SD; the area under the NNC0705-0001 plasma concentration-time curve after a single dose | From pre-dose (day 1 or day 8) to day 2 or day 9 | Measured in Hour x Micromole (hr×μM). |
| PART A: Number of treatment emergent adverse events (TEAE) | From time of dosing (day 1) to end of study (day 7) | Measured in number of events. |
| PART B: Number of TEAEs | From time of dosing (day 1) to end of study (day 13) | Measured in number of events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PART A: AUC0-∞, SD; the area under the NNC0705-0001 plasma concentration-time curve from time 0 to infinity after a single dose | From pre-dose (day 1) to day 5 | Measured in hr×μM. |
| PART A: Cmax, SD; the maximum plasma concentration of NNC0705-0001 after a single dose | From pre-dose (day 1) to day 5 | Measured in micromole (μM). |
| PART B: AUCtau, MD; the area under the NN0705-0001 plasma concentration-time curve from time 0 to tau after the last dose | From pre-dose (day 7) to end of study (day 13) | Measured in hr×μM. |
| PART C: Cmax, SD; the maximum plasma concentration of NNC0705-0001 after a single dose | From pre-dose (day 1 or day 8) to day 2 or day 9 | Measured in μM. |
| PART B: Cmax, MD; the maximum plasma concentration of NNC0705-0001 after last dose | From pre-dose (day 7) to end of study (day 13) | Measured in μM. |
| PART C: Number of TEAEs | From time of dosing (day 1) to end of study (day 12) | Measured in number of events. |
| 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 | From pre-dose (day 1) to day 5 | Measured in hr×μM. |
Countries
Netherlands
Contacts
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed