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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT03010475 (opens ClinicalTrials.gov in a new tab)Other idNN9924-4250Other id2015-003908-23Other idU1111-1173-8618Other id2015

Overview

Status
Completed
Phase
Phase 1
Enrollment
41 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United Kingdom

Start
5 Jan 2017
Primary completion
4 Jun 2017
Completion
9 Aug 2017
First posted
5 Jan 2017 (estimated)
Last update posted
20 Dec 2017
Conditions
Diabetes · Healthy

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20172018
  1. Ph 1

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

    NCT03010475

    5 Jan 2017 to 9 Aug 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • FurosemideDrug
  • RosuvastatinDrug
  • SNACDrug
  • SemaglutideDrug

Arms1

  • Experimental

    Furosemide/Rosuvastatin/SNAC/Semaglutide

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Area under the furosemide plasma concentration-time curve

    Time frame · day 1, day 7, day 54

    Registry description

    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

    Registry description

    Based on sampling between 0 and 96 hours

Secondary outcomes(2)
  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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2021

9 results

Effect of Oral Semaglutide on the Pharmacokinetics of Levonorgestrel and Ethinylestradiol in Healthy Postmenopausal Women and Furosemide and Rosuvastatin in Healthy Subjects.

Jordy et al. 2021Clinical pharmacokineticscited by 19

PMID 33782832PMC8416862DOI 10.1007/s40262-020-00976-xPUB-33782832

Free to read · publisher termsCC BY-NC9 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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