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Trial · Interventional

CompletedPhase 1Registry data

Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Hepatic Impairment

NCTNCT02016911 (opens ClinicalTrials.gov in a new tab)Other idNN9924-4082Other id2013-000550-21Other idU1111-1139-1272
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
56 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Not randomized · Open label (no masking)
Countries
3 countries

Czechia, Poland, Slovakia

Start
12 Dec 2013
Primary completion
12 Jan 2015
Completion
12 Jan 2015
First posted
20 Dec 2013 (estimated)
Last update posted
15 May 2018
Conditions
Diabetes · Diabetes Mellitus, Type 2 · Healthy

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2013201420152016
  1. Ph 1

    Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Hepatic Impairment

    NCT02016911

    12 Dec 2013 to 12 Jan 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 the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability of oral semaglutide (NNC0113-0217) in subjects with mild, moderate and severe degrees of hepatic impairment compared to subjects with normal hepatic function.

Interventions

  • semaglutideDrug

Arms2

  • Experimental

    Subjects with hepatic impairment

  • Active comparator

    Subjects with normal hepatic function

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Area under the semaglutide plasma concentration curve

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

Secondary outcomes(3)

  1. Maximum observed semaglutide plasma concentration

    Time frame · 0 to 24 hours after the 10th dosing

  2. Area under the SNAC (Sodium N-[8-(2-hydroxybenzoyl) amino] caprylate /salcaprozate sodium) plasma concentration time curve

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

  3. Maximum observed SNAC plasma concentration

    Time frame · 0 to 24 hours after the 10th dosing

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: Clinical trial · 2018

5 results

Pharmacokinetics, Safety, and Tolerability of Oral Semaglutide in Subjects With Hepatic Impairment.

Baekdal et al. 2018Journal of clinical pharmacologycited by 70

PMID 29693715PMC6175428DOI 10.1002/jcph.1131PUB-29693715

Free to read · publisher termsCC BY-NC5 results
Read at sourceSee results (5)

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 85 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Subject with normal hepatic function or hepatic impairment (mild, moderate or severe) * Body mass index (BMI) 18.5-40.0 kg/m\^2 (both inclusive) 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 * History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease * Uncontrolled hypertension (defined as systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg) * Any donation of blood or plasma in excess of 400 mL within the 3 months preceding screening * History of significant drug abuse, or a positive drug test at the screening visit (Visit 2)

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