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CompletedNCT03010475Updated Dec 20, 2017

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

A Phase 1 interventional study of Furosemide and Rosuvastatin in Diabetes and Healthy, sponsored by Novo Nordisk A/S. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-20.

Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
41
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes
  • Healthy
03

In context

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
41 participants (actual)

Study arms

  • Experimental
    Furosemide/Rosuvastatin/SNAC/Semaglutide

    Drug: Furosemide · Drug: Rosuvastatin · Drug: SNAC · Drug: Semaglutide

Interventions

  • DrugFurosemide

    Oral administration A total of three single doses.

  • DrugRosuvastatin

    Oral administration. A total of three single doses.

  • DrugSNAC

    Oral administration. A total of five single doses.

  • DrugSemaglutide

    Oral administration. Once daily.

06

What researchers measure

Primary outcomes

  1. Area under the furosemide plasma concentration-time curve

    Based on sampling between 0 and 12 hours

    Time frame: day 1, day 7, day 54

  2. Area under the rosuvastatin plasma concentration-time curve

    Based on sampling between 0 and 96 hours

    Time frame: day 2, day 8, day 55

Secondary outcomes

  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

07

Study locations

1 site
  • Novo Nordisk Investigational Site
    Harrow, HA1 3UJ, United Kingdom
08

References and documents

Publications

  • 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. PubMed 33782832 ↗

Individual participant data

Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03010475
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Jan 5, 2017
Start date
Jan 5, 2017
Primary completion
Jun 4, 2017
Completion
Aug 9, 2017
Last update
Dec 20, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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