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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03010475
Recruitment Status : Completed
First Posted : January 5, 2017
Last Update Posted : December 20, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetes Healthy Drug: Furosemide Drug: Rosuvastatin Drug: SNAC Drug: Semaglutide Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial Investigating the Effect of Oral Semaglutide on the Pharmacokinetics of Furosemide and Rosuvastatin in Healthy Subjects.
Actual Study Start Date : January 5, 2017
Actual Primary Completion Date : June 4, 2017
Actual Study Completion Date : August 9, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Furosemide/Rosuvastatin/SNAC/Semaglutide Drug: Furosemide
Oral administration A total of three single doses.

Drug: Rosuvastatin
Oral administration. A total of three single doses.

Drug: SNAC
Oral administration. A total of five single doses.

Drug: Semaglutide
Oral administration. Once daily.

Primary Outcome Measures :
  1. Area under the furosemide plasma concentration-time curve [ Time Frame: day 1, day 7, day 54 ]
    Based on sampling between 0 and 12 hours

  2. Area under the rosuvastatin plasma concentration-time curve [ Time Frame: day 2, day 8, day 55 ]
    Based on sampling between 0 and 96 hours

Secondary Outcome Measures :
  1. Maximum observed furosemide plasma concentration [ Time Frame: day 1, day 7, day 54 ]
  2. Maximum observed rosuvastatin plasma concentration [ Time Frame: day 2, day 8, day 55 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03010475

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United Kingdom
Novo Nordisk Investigational Site
Harrow, United Kingdom, HA1 3UJ
Sponsors and Collaborators
Novo Nordisk A/S

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Responsible Party: Novo Nordisk A/S Identifier: NCT03010475    
Other Study ID Numbers: NN9924-4250
2015-003908-23 ( EudraCT Number )
U1111-1173-8618 ( Other Identifier: UTN )
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators