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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1315-6842 | Other Identifier | World Health Organization | |
| 2024-519478-38 | Other Identifier | European Medical Agency (EMA) |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: NNC0705-0001 | Experimental | Participants will receive 6 different single ascending doses of NNC0705-0001 via oral administration. |
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| Part A: Placebo | Placebo Comparator | Participants will receive single ascending dose of placebo matching NNC0705-0001 via oral administration. |
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| Part B: NNC0705-0001 | Experimental | Participants will receive 4 different multiple ascending doses of NNC0705-0001 via oral administration. |
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| Part B: Placebo | Placebo Comparator | Participants will receive multiple ascending doses of placebo matching NNC0705-0001 via oral administration. |
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| Part C: NNC0705-0001 | Experimental | Participants will receive 2 separate single doses of NNC0705-0001 at a previously safety-cleared dose level in PART A, either in a fed or fasted state. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0705-0001 | Drug | NNC0705-0001 will be administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| PART A: Number of treatment emergent adverse events (TEAE) | Measured in number of events. | From time of dosing (day 1) to end of study (day 7) |
| PART B: Number of TEAEs | Measured in number of events. | From time of dosing (day 1) to end of study (day 13) |
| AUC, SD; the area under the NNC0705-0001 plasma concentration-time curve after a single dose | Measured in Hour x Micromole (hr×μM). | From pre-dose (day 1 or day 8) to day 2 or day 9 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Measured in hr×μM. | From pre-dose (day 1) to day 5 |
| PART A: AUC0-∞, SD; the area under the NNC0705-0001 plasma concentration-time curve from time 0 to infinity after a single dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON - location Groningen | Groningen | 9728 NZ | Netherlands |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
| Placebo | Drug | Placebo matching NNC0705-0001 will be administered orally. |
|
Measured in hr×μM. |
| From pre-dose (day 1) to day 5 |
| PART A: Cmax, SD; the maximum plasma concentration of NNC0705-0001 after a single dose | Measured in micromole (μM). | From pre-dose (day 1) to day 5 |
| PART B: AUCtau, MD; the area under the NN0705-0001 plasma concentration-time curve from time 0 to tau after the last dose | Measured in hr×μM. | From pre-dose (day 7) to end of study (day 13) |
| PART B: Cmax, MD; the maximum plasma concentration of NNC0705-0001 after last dose | Measured in μM. | From pre-dose (day 7) to end of study (day 13) |
| PART C: Cmax, SD; the maximum plasma concentration of NNC0705-0001 after a single dose | Measured in μM. | From pre-dose (day 1 or day 8) to day 2 or day 9 |
| PART C: Number of TEAEs | Measured in number of events. | From time of dosing (day 1) to end of study (day 12) |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |