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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy, Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: semaglutide


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |