NCT03010475

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P50-P75 for phase_1 diabetes

Timeline
Completed

Started Jan 2017

Typical duration for phase_1 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 5, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

January 5, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2017

Completed
Last Updated

December 20, 2017

Status Verified

December 1, 2017

Enrollment Period

5 months

First QC Date

January 3, 2017

Last Update Submit

December 19, 2017

Conditions

DiabetesHealthy

Outcome Measures

Primary Outcomes (2)

  • Area under the furosemide plasma concentration-time curve

    Based on sampling between 0 and 12 hours

    day 1, day 7, day 54

  • Area under the rosuvastatin plasma concentration-time curve

    Based on sampling between 0 and 96 hours

    day 2, day 8, day 55

Secondary Outcomes (2)

  • Maximum observed furosemide plasma concentration

    day 1, day 7, day 54

  • Maximum observed rosuvastatin plasma concentration

    day 2, day 8, day 55

Study Arms (1)

Furosemide/Rosuvastatin/SNAC/Semaglutide

EXPERIMENTAL
Drug: FurosemideDrug: RosuvastatinDrug: SNACDrug: Semaglutide

Interventions

FurosemideDRUG

Oral administration A total of three single doses.

Furosemide/Rosuvastatin/SNAC/Semaglutide
RosuvastatinDRUG

Oral administration. A total of three single doses.

Furosemide/Rosuvastatin/SNAC/Semaglutide
SNACDRUG

Oral administration. A total of five single doses.

Furosemide/Rosuvastatin/SNAC/Semaglutide
SemaglutideDRUG

Oral administration. Once daily.

Furosemide/Rosuvastatin/SNAC/Semaglutide

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Harrow, HA1 3UJ, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 33782832DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

FurosemideRosuvastatin Calciumsemaglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

SulfanilamidesSulfonamidesAmidesOrganic ChemicalsAniline CompoundsAminesSulfonesSulfur CompoundsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2017

First Posted

January 5, 2017

Study Start

January 5, 2017

Primary Completion

June 4, 2017

Study Completion

August 9, 2017

Last Updated

December 20, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will share

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Locations

GB(1)