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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03010475
• Other study ID #: NN9924-4250
• Secondary ID: 2015-003908-23U1
• Status: Completed
• Phase: Phase 1
• First received: January 3, 2017
• Last updated: December 19, 2017
• Start date: January 5, 2017
• Est. completion date: August 9, 2017

Study information

• Verified date: December 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: August 9, 2017
• Est. primary completion date: June 4, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• Furosemide
Oral administration A total of three single doses.
• Rosuvastatin
Oral administration. A total of three single doses.
• SNAC
Oral administration. A total of five single doses.
• Semaglutide
Oral administration. Once daily.

Locations

Country	Name	City	State
United Kingdom	Novo Nordisk Investigational Site	Harrow

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the furosemide plasma concentration-time curve	Based on sampling between 0 and 12 hours	day 1, day 7, day 54
Primary	Area under the rosuvastatin plasma concentration-time curve	Based on sampling between 0 and 96 hours	day 2, day 8, day 55
Secondary	Maximum observed furosemide plasma concentration		day 1, day 7, day 54
Secondary	Maximum observed rosuvastatin plasma concentration		day 2, day 8, day 55