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

Phase 1

Completed

• Conditions: Diabetes; Healthy
• Interventions: Drug: Furosemide; Drug: Rosuvastatin; Drug: SNAC; Drug: Semaglutide

• Registration Number: NCT03010475
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-03
• Study First Submitted QC: 2017-01-03
• Study Start: 2017-01-05
• Study First Posted: 2017-01-05
• Primary Completion: 2017-06-04
• Study Completion: 2017-08-09
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-19
• Last Update Posted: 2017-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Furosemide/Rosuvastatin/SNAC/Semaglutide	Rosuvastatin	-
Furosemide/Rosuvastatin/SNAC/Semaglutide	SNAC	-
Furosemide/Rosuvastatin/SNAC/Semaglutide	Furosemide	-
Furosemide/Rosuvastatin/SNAC/Semaglutide	Semaglutide	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Maximum observed furosemide plasma concentration	day 1, day 7, day 54
Maximum observed rosuvastatin plasma concentration	day 2, day 8, day 55

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Harrow, United Kingdom