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

May 9, 2018 updated by: Novo Nordisk A/S

Investigation of Pharmacokinetics, 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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Praha 10, Czechia, 10034
        • Novo Nordisk Investigational Site
      • Praha 7, Czechia, 17000
        • Novo Nordisk Investigational Site
  • Poland
      • Bialystok, Poland, 15-879
        • Novo Nordisk Investigational Site
      • Warszawa, Poland, 02-507
        • Novo Nordisk Investigational Site
      • Wolomin, Poland, 05-200
        • Novo Nordisk Investigational Site
  • Slovakia
      • Bratislava, Slovakia, 83101
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Subjects with hepatic impairment
Drug: semaglutide
Once daily oral administration of semaglutide formulated with SNAC. Dose escalation, with 5 days on 5 mg followed by 5 days on 10 mg
Active Comparator: Subjects with normal hepatic function
Drug: semaglutide
Once daily oral administration of semaglutide formulated with SNAC. Dose escalation, with 5 days on 5 mg followed by 5 days on 10 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the semaglutide plasma concentration curve
Time Frame: From time 0 to 24 hours after the 10th dosing
From time 0 to 24 hours after the 10th dosing

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum observed semaglutide plasma concentration
Time Frame: 0 to 24 hours after the 10th dosing
0 to 24 hours after the 10th dosing
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
From time 0 to 24 hours after the 10th dosing
Maximum observed SNAC plasma concentration
Time Frame: 0 to 24 hours after the 10th dosing
0 to 24 hours after the 10th dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2013

Primary Completion (Actual)

January 12, 2015

Study Completion (Actual)

January 12, 2015

Study Registration Dates

First Submitted

December 12, 2013

First Submitted That Met QC Criteria

December 16, 2013

First Posted (Estimate)

December 20, 2013

Study Record Updates

Last Update Posted (Actual)

May 15, 2018

Last Update Submitted That Met QC Criteria

May 9, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9924-4082
  • 2013-000550-21 (EudraCT Number)
  • U1111-1139-1272 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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