A Trial Investigating the Effect of Oral Semaglutide on the Pharmacokinetics of Furosemide and Rosuvastatin in Healthy Subjects

Study Overview
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Brief Summary
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This trial is conducted in Europe. Tha aim of this trial is to investigate the effect of oral semaglutide on the pharmacokinetics of furosemide and rosuvastatin in healthy subjects.

Official Title
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A Trial Investigating the Effect of Oral Semaglutide on the Pharmacokinetics of Furosemide and Rosuvastatin in Healthy Subjects.

Conditions
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Diabetes, Healthy

Intervention / Treatment
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* Drug: Furosemide
* Drug: Rosuvastatin
* Drug: SNAC
* Drug: Semaglutide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial Male or female, aged 18-65 years (both inclusive) at the time of signing informed consent Body mass index (BMI) between 20.0-29.9 kg/m^2 (both inclusive) Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiography and clinical laboratory tests performed during the screening visit, as judged by the investigator Exclusion Criteria: Smoker (defined as a subject who is smoking at least one cigarette or the equivalent per day) Any blood draw in excess of 25 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding screening History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) Have personal or family history of myopathy Previous history of muscular toxicity with another HMG-CoA reductase inhibitor or fibrate Thyroid-Stimulating Hormone outside lower limit of normal minus 10 percent and upper limit of normal plus 10 percent Creatine kinase above 5 x upper limit of normal Asian subject

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Furosemide/Rosuvastatin/SNAC/Semaglutide<br> | Drug: Furosemide<br>* Oral administration A total of three single doses.<br>Drug: Rosuvastatin<br>* Oral administration. A total of three single doses.<br>Drug: SNAC<br>* Oral administration. A total of five single doses.<br>Drug: Semaglutide<br>* Oral administration. Once daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the furosemide plasma concentration-time curve | Based on sampling between 0 and 12 hours | day 1, day 7, day 54 | 
| Area under the rosuvastatin plasma concentration-time curve | Based on sampling between 0 and 96 hours | day 2, day 8, day 55 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed furosemide plasma concentration |  | day 1, day 7, day 54 | 
| Maximum observed rosuvastatin plasma concentration |  | day 2, day 8, day 55 |