Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2015-005558-36 | EudraCT Number | ||
| U1111-1177-2807 | Other Identifier | WHO |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial is conducted in Europe. The aim of this trial is to investigate the influence of oral semaglutide on the pharmacokinetics (the exposure of the trial drug in the body) of levothyroxine and the influence of co-administered tablets on the pharmacokinetics of semaglutide administered orally in healthy subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levothyroxine/SNAC/Placebo/Semaglutide | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | Oral administration once daily alone or together with levothyroxine or Placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Baseline-corrected area under the total T4 serum concentration-time curve from 0 to 48 hours after a single dose of levothyroxine | On day 1 (levothyroxine administered alone), on day 38 (levothyroxine co-administered with SNAC) and on day 89 (levothyroxine co-administered with oral semaglutide) | |
| Area under the semaglutide plasma concentration-time curve during a dosing interval (0-24 hours) at steady state | On day 88 (oral semaglutide administered alone) and on day 139 (oral semaglutide co-administered with placebo tablets) |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline-corrected maximum observed total T4 serum concentration from 0 to 48 hours after a single dose of levothyroxine | On day 1 (levothyroxine administered alone), on day 38 (levothyroxine co-administered with SNAC) and on day 89 (levothyroxine co-administered with oral semaglutide) | |
| Maximum observed semaglutide plasma concentration during a dosing interval from (0-24 hours) at steady state |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Berlin | 14050 | Germany |
According to Novo Nordisk disclosure commitment on novonordisk-trials.com
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| SNAC | Drug | Oral administration once daily alone or together with levothyroxine or semaglutide |
|
| Levothyroxine | Drug | Oral administration alone or together with SNAC or oral semaglutide |
|
| Placebo | Drug | Oral administration once daily together with semaglutide |
|
| On day 88 (oral semaglutide administered alone) and on day 139 (oral semaglutide co-administered with placebo tablets) |
| Area under the SNAC plasma concentration-time curve during a dosing interval (0-24 hours) at steady state | On day 88 (oral semaglutide administered alone) and on day 139 (oral semaglutide co-administered with placebo tablets) |
| Maximum observed SNAC plasma concentration during a dosing interval (0-24 hours) at steady state | On day 88 (oral semaglutide administered alone) and on day 139 (oral semaglutide co-administered with placebo tablets) |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000591245 | semaglutide |
| D013974 | Thyroxine |
| ID | Term |
|---|---|
| D013963 | Thyroid Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided