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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes

Treatments: Drug: Semaglutide; Drug: SNAC; Drug: Furosemide; Drug: Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03010475

NN9924-4250

U1111-1173-8618 (Other Identifier)

2015-003908-23 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

Furosemide/Rosuvastatin/SNAC/Semaglutide

Experimental group

Treatment:

Drug: SNAC

Drug: Furosemide

Drug: Semaglutide

Drug: Rosuvastatin