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

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

Sponsors

Lead Sponsor: Novo Nordisk A/S

Source Novo Nordisk A/S
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.

Overall Status Completed
Start Date December 12, 2013
Completion Date January 12, 2015
Primary Completion Date January 12, 2015
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Area under the semaglutide plasma concentration curve From time 0 to 24 hours after the 10th dosing
Secondary Outcome
Measure Time Frame
Maximum observed semaglutide plasma concentration 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 From time 0 to 24 hours after the 10th dosing
Maximum observed SNAC plasma concentration 0 to 24 hours after the 10th dosing
Enrollment 56
Condition
Intervention

Intervention Type: Drug

Intervention Name: semaglutide

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

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)

Gender: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Global Clinical Registry (GCR, 1452) Study Director Novo Nordisk A/S
Location
Facility:
Novo Nordisk Investigational Site | Praha 10, 10034, Czechia
Novo Nordisk Investigational Site | Praha 7, 17000, Czechia
Novo Nordisk Investigational Site | Bialystok, 15-879, Poland
Novo Nordisk Investigational Site | Warszawa, 02-507, Poland
Novo Nordisk Investigational Site | Wolomin, 05-200, Poland
Novo Nordisk Investigational Site | Bratislava, 83101, Slovakia
Location Countries

Czechia

Poland

Slovakia

Verification Date

May 2018

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Subjects with hepatic impairment

Type: Experimental

Label: Subjects with normal hepatic function

Type: Active Comparator

Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov