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Trial · Interventional

CompletedPhase 1Registry data

Investigating the Influence of Omeprazole on the Pharmacokinetics of Oral Semaglutide in Healthy Subjects

NCTNCT02249871 (opens ClinicalTrials.gov in a new tab)Other idNN9924-4141Other id2013-005513-12Other idU1111-1151-5077

Overview

Status
Completed
Phase
Phase 1
Enrollment
54 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

Germany

Start
24 Sept 2014
Primary completion
1 Apr 2015
Completion
1 Apr 2015
First posted
26 Sept 2014 (estimated)
Last update posted
13 Aug 2018
Conditions
Diabetes · Healthy

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201420152016
  1. Ph 1

    Investigating the Influence of Omeprazole on the Pharmacokinetics of Oral Semaglutide in Healthy Subjects

    NCT02249871

    24 Sept 2014 to 1 Apr 2015

Registry summary

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

This trial is conducted in Europe. The aim of this trial is to investigate the influence of omeprazole on the pharmacokinetics (the exposure of the trial drug in the body) of oral semaglutide in healthy subjects.

Interventions

  • semaglutideDrug
  • OmeprazoleDrug

Arms2

  • Experimental

    Semaglutide

  • Experimental

    Semaglutide + Omeprazole

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Area under the semaglutide plasma concentration time curve

    Time frame · From time 0 to 24 hours after the 10th daily dose

Secondary outcomes(2)
  1. Area under the SNAC plasma concentration time curve

    Time frame · From time 0 to 24 hours after the 10th daily dose

  2. Number of hypoglycaemic episodes

    Time frame · From first dosing (Day 1) to completion of the follow-up visit (Day 43 (± 2 days))

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

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2018

4 results

A randomized study investigating the effect of omeprazole on the pharmacokinetics of oral semaglutide.

Bækdal et al. 2018Expert opinion on drug metabolism & toxicologycited by 48

PMID 29897249DOI 10.1080/17425255.2018.1488965PUB-29897249

Full text at the publisher4 results

More studies

1 study on this page

PubMed tag: none · 2021

Clinical Pharmacokinetics of Oral Semaglutide: Analyses of Data from Clinical Pharmacology Trials.

Overgaard et al. 2021Clinical pharmacokineticscited by 103

PMID 33969456PMC8505367DOI 10.1007/s40262-021-01025-xPUB-33969456

Free to read · publisher termsCC BY-NC
Read at source

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Male or female age 18-75 years (both inclusive) at time of signing informed consent * Body mass index of 18.5-29.9 kg/m\^2 (both inclusive) * A good general health based on medical history, physical examination, and results of vital signs, electrocardiogram and laboratory safety tests performed during the screening visit, as judged by the investigator Exclusion Criteria: * Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods. Female of child bearing potential must use effective methods of birth control for the duration of the trial and for 5 weeks following last dose. Only highly effective methods of birth control are accepted (i.e., one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices) * History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease * Hypertension (defined as sitting systolic blood pressure above or equal to 140 mmHg and/or diastolic blood pressure above or equal to 90 mmHg). If white-coat hypertension is suspected at the screening visit a repeated measurement is allowed * 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

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