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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2, Healthy

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
semaglutide
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Subjects with hepatic impairment

Subjects with normal hepatic function

Arm Description

Outcomes

Primary Outcome Measures

Area under the semaglutide plasma concentration curve

Secondary Outcome Measures

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

Full Information

First Posted
December 12, 2013
Last Updated
May 9, 2018
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT02016911
Brief Title
Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Hepatic Impairment
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
December 12, 2013 (Actual)
Primary Completion Date
January 12, 2015 (Actual)
Study Completion Date
January 12, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2, Healthy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subjects with hepatic impairment
Arm Type
Experimental
Arm Title
Subjects with normal hepatic function
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
semaglutide
Intervention Description
Once daily oral administration of semaglutide formulated with SNAC. Dose escalation, with 5 days on 5 mg followed by 5 days on 10 mg
Primary Outcome Measure Information:
Title
Area under the semaglutide plasma concentration curve
Time Frame
From time 0 to 24 hours after the 10th dosing
Secondary Outcome Measure Information:
Title
Maximum observed semaglutide plasma concentration
Time Frame
0 to 24 hours after the 10th dosing
Title
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
Title
Maximum observed SNAC plasma concentration
Time Frame
0 to 24 hours after the 10th dosing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Praha 10
ZIP/Postal Code
10034
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Praha 7
ZIP/Postal Code
17000
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Bialystok
ZIP/Postal Code
15-879
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Wolomin
ZIP/Postal Code
05-200
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Bratislava
ZIP/Postal Code
83101
Country
Slovakia

12. IPD Sharing Statement

Citations:
PubMed Identifier
29693715
Citation
Baekdal TA, Thomsen M, Kupcova V, Hansen CW, Anderson TW. Pharmacokinetics, Safety, and Tolerability of Oral Semaglutide in Subjects With Hepatic Impairment. J Clin Pharmacol. 2018 Oct;58(10):1314-1323. doi: 10.1002/jcph.1131. Epub 2018 Apr 25.
Results Reference
result
PubMed Identifier
33969456
Citation
Overgaard RV, Navarria A, Ingwersen SH, Baekdal TA, Kildemoes RJ. Clinical Pharmacokinetics of Oral Semaglutide: Analyses of Data from Clinical Pharmacology Trials. Clin Pharmacokinet. 2021 Oct;60(10):1335-1348. doi: 10.1007/s40262-021-01025-x. Epub 2021 May 10.
Results Reference
derived
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

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

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