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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1285-1593 | Other Identifier | World Health Organization (WHO) |
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In this trial, medicine NNC0560-0004 given in capsule form will be compared to placebo in healthy volunteers.
Participants will either get NNC0560-0004 or placebo. Which treatment they get is decided by chance.
This is a first in human trial, which means that this is the first time that NNC0560-0004 is given to humans.
The study will last for about two weeks plus the screening period (approximately 42 days) which in all is about 8 weeks.
Women must be of non-childbearing potential thus you cannot take part if you are pregnant, can become pregnant, breast-feeding or plan to get pregnant during the study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0560-0004 | Experimental | The study will be conducted in 3 parts. Participants will be randomized to receive NNC0560-0004 in Part A: Single ascending dose (SAD) Part B: Multiple ascending dose (MAD) No randomisation - only active treatment in Part C: Single dose |
|
| Placebo (NNC0560-0004) | Placebo Comparator | Participant will be randomized to receive placebo in: Part A: Single ascending dose (SAD) Part B: Multiple ascending dose (MAD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0560-0004 | Drug | NNC0560-0004, Oral administration (taken through the mouth) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Number of treatment-emergent adverse events (TEAE) | Number of events | From pre-dose (day 1) to end of study, Part A (up to day 13) |
| Part B: Number of treatment-emergent adverse events (TEAE) | Number of events | From pre-dose (day 1) to end of study, Part B (up to day 26) |
| Part C: Number of treatment-emergent adverse events (TEAE) | Number of events | From pre-dose (day 1) to end of study, Part C (up to day 84) |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: AUC0-∞, SD: the area under the NNC0560-0004 plasma concentration-time curve from time 0 to infinity after a single dose | h*nmol/L | From pre-dose (day 1) to end of study, Part A (up to day 13) |
| Part A: Cmax, SD: the maximum plasma concentration of NNC0560-0004 after a single dose |
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Key inclusion criteria:
Female, of non-childbearing potential, or male, both genders aged 18-55 years (both inclusive) at the time of signing informed consent.
Body Mass Index (BMI) between 18.5 and 29.9 kg/m^2 (both inclusive) 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 including inflammatory markers performed during the screening visit, as judged by the investigator
CYP2D6 phenotype:
Key exclusion criteria:
Any disorder/condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
Known history of histamine intolerance or severe anaphylactic reactions
Abnormal values at screening for any of the following laboratory parameters
Aspartate aminotransferase (AST) greater than Upper limit of normal (ULN)+10%.
Alanine aminotransferase (ALT) greater than ULN +10%.
Bilirubin (except if known Gilbert's syndrome) greater than ULN +10%.
Creatinine greater than ULN.
a.eGFR below 90 ml/min/1.73m^2
Glycated haemoglobin (HbA1c) greater than or equal to 5.7% (39 mmol/mol).
CYP2D6 unknown phenotype
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwick Park Hosptial | Watford | Middlesex | HA1 3UJ | United Kingdom |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
| Placebo (NNC0560-0004) |
| Drug |
Placebo matching NNC0560-0004, Oral administration (taken through the mouth) |
|
nmol/L |
| From pre-dose (day 1) to end of study, Part A (up to day 13) |
| Part A: tmax, SD: the time to maximum concentration of NNC0560-0004 after a single dose | hour | From pre-dose (day 1) to end of study, Part A (up to day 13) |
| Part A:t½, SD: the terminal half-life of NNC0560-0004 after a single dose | hour | From pre-dose (day 1) to end of study, Part A (up to day 13) |
| Part B: AUC0-24h, MD: the area under the NNC0560-0004 plasma concentration-time curve in the dosing interval after last dosing | h*nmol/L | From pre-dose on day 14 until end of study, Part B (up to day 26) (24 hours post-dose) |
| Part B: Cmax, MD: the maximum plasma concentration of NNC0560-0004 after last dosing | nmol/L | From pre-dose on day 14 to end of study, Part B (up to day 26) |
| Part B:tmax, MD: the time to maximum concentration of NNC0560-0004 after last dosing | hour | From pre-dose on day 14 to end of study, Part B (up to day 26) |
| Part B:t½, MD: the terminal half-life of NNC0560-0004 after last dosing | hour | From pre-dose on day 14 to end of study, Part B (up to day 26) |
| Part C: AUC0-∞, SD: the area under the NNC0560-0004 plasma concentration-time curve from time 0 to infinity after a single dose | h*nmol/L | From pre-dose (day 1) to end of study, Part C (up to day 84) |
| Part C: Cmax, SD: the maximum plasma concentration of NNC0560-0004 after a single dose | nmol/L | From pre-dose (day 1) to end of study, Part C (up to day 84) |
| Part C: tmax, SD: the time to maximum concentration of NNC0560-0004 after a single dose | hour | From pre-dose (day 1) to end of study, Part C (up to day 84) |
| Part C: t½, SD: the terminal half-life of NNC0560-0004 after a single dose | hour | From pre-dose (day 1) to end of study, Part C (up to day 84) |