Clinical trial NCT03010475: A Trial Investigating the Effect of Oral Semaglutide on the Pharmacokinetics of Furosemide and Rosuvastatin in Healthy Subjects
Official title: A Trial Investigating the Effect of Oral Semaglutide on the Pharmacokinetics of Furosemide and Rosuvastatin in Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2017-01-05
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Area under the furosemide plasma concentration-time curve
timeFrame: day 1, day 7, day 54
measure: Area under the rosuvastatin plasma concentration-time curve
timeFrame: day 2, day 8, day 55
Secondary outcomes:
measure: Maximum observed furosemide plasma concentration
timeFrame: day 1, day 7, day 54
measure: Maximum observed rosuvastatin plasma concentration
timeFrame: day 2, day 8, day 55
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
References:
citation: Jordy AB, Albayaty M, Breitschaft A, Anderson TW, Christiansen E, Houshmand-Oregaard A, Manigandan E, Baekdal TA. Effect of Oral Semaglutide on the Pharmacokinetics of Levonorgestrel and Ethinylestradiol in Healthy Postmenopausal Women and Furosemide and Rosuvastatin in Healthy Subjects. Clin Pharmacokinet. 2021 Sep;60(9):1171-1185. doi: 10.1007/s40262-020-00976-x.