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

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2; Healthy
• Interventions: Drug: semaglutide

• Registration Number: NCT02016911
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-12
• Study First Submitted: 2013-12-12
• Study First Submitted QC: 2013-12-16
• Study First Posted: 2013-12-20
• Primary Completion: 2015-01-12
• Study Completion: 2015-01-12
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-09
• Last Update Posted: 2018-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subjects with normal hepatic function	semaglutide	-
Subjects with hepatic impairment	semaglutide	-

Primary Outcome Measures

Name	Time	Method
Area under the semaglutide plasma concentration curve	From time 0 to 24 hours after the 10th dosing

Secondary Outcome Measures

Name	Time	Method
Maximum observed SNAC plasma concentration	0 to 24 hours after the 10th dosing
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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇸🇰 Bratislava, Slovakia