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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-012366-31 | EudraCT Number | ||
| U1111-1112-7564 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability and bioavailability (exploring absorption of drug in body) of NN9924 in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trial part 1 | Experimental |
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| Trial part 2 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NN9924 (oral) | Drug | Subjects will be randomized to receive a single dose of NN9924, at escalating dose levels. Progression to next dose will be based on safety evaluation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number and severity of adverse events (AEs) recorded | from dosing to Day 22 |
| Measure | Description | Time Frame |
|---|---|---|
| The uptake in blood of oral NN9924 compared to i.v. and s.c. administration of the same compound | from 0 to 504 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Harrow | HA1 3UJ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30565096 | Derived | Granhall C, Donsmark M, Blicher TM, Golor G, Sondergaard FL, Thomsen M, Baekdal TA. Safety and Pharmacokinetics of Single and Multiple Ascending Doses of the Novel Oral Human GLP-1 Analogue, Oral Semaglutide, in Healthy Subjects and Subjects with Type 2 Diabetes. Clin Pharmacokinet. 2019 Jun;58(6):781-791. doi: 10.1007/s40262-018-0728-4. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| placebo | Drug | Subjects will receive a single dose of placebo as a comparator to NN9924, at all dose levels. |
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| NN9924 (oral) | Drug | Subjects will be randomized to receive a single dose of NN9924 in one of three different concentrations. The dose will be selected based on the results of part 1. |
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| placebo | Drug | Subjects will be randomized to receive a single dose of placebo. |
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| NN9924 (s.c.) | Drug | As an active comparator, one standard dose will be given s.c. (under the skin) at one study visit |
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| NN9924 (i.v.) | Drug | As an active comparator, one standard dose will be given i.v. (into the vein) at one study visit. |
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