Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Mild and Moderate Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic Function.

Study Overview
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Brief Summary
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This trial is conducted in Europe. The aim of this trial is to investigate the effect of abnormal liver (hepatic) function on the amount of trial drug getting into the body and removal of the drug from the body (this is called pharmacokinetics). In this trial the participants will receive three subcutaneous (under the skin) injections of the trial drug somapacitan. Somapacitan is a long-acting growth hormone analogue (a drug similar to human growth hormone) intended for once-weekly subcutaneous administration.

Official Title
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Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Mild and Moderate Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic Function

Conditions
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Growth Hormone Disorder, Adult Growth Hormone Deficiency, Growth Hormone Deficiency in Children

Intervention / Treatment
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* Drug: Somapacitan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged 18-75 years (both inclusive) Body mass index of 18.5-39.9 kg/sqm (both inclusive) Subjects with normal hepatic function or hepatic impairment (mild or moderate) Exclusion Criteria: Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice) for at least 16 days after the last trial product administration Male of reproductive age who or whose partner(s) is not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) or male who is not willing to refrain from donating semen for at least 16 days after last trial product administration Any blood draw in excess of 25 mL in the past 30 days, or donation of blood or plasma in excess of 400 mL within the 90 days preceding screening Any disorder, except for conditions associated with hepatic impairment in the group of subjects with compromised hepatic function, which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Normal hepatic function<br>Subjects with normal hepatic function | Drug: Somapacitan<br>* 3 once-weekly subcutaneous administrations (s.c., under the skin) of somapacitan with a dose of 0.08 mg/kg<br>|
| Experimental: Mild hepatic impairment<br>Subjects with mild hepatic impairment | Drug: Somapacitan<br>* 3 once-weekly subcutaneous administrations (s.c., under the skin) of somapacitan with a dose of 0.08 mg/kg<br>|
| Experimental: Moderate hepatic impairment<br>Subjects with moderate hepatic impairment | Drug: Somapacitan<br>* 3 once-weekly subcutaneous administrations (s.c., under the skin) of somapacitan with a dose of 0.08 mg/kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the somapacitan serum concentration time curve | Calculated based on somapacitan measured in blood | From time 0 to 168 hours after the last dosing on Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum serum concentration of somapacitan | Calculated based on plasma somapacitan activity measured in blood | After the last dosing on Day 15 until Day 43 | 
| Time to maximum serum concentration of somapacitan | Calculated based on plasma somapacitan activity measured in blood | After the last dosing on Day 15 until Day 43 | 
| Incidence of adverse events | Count | From first dosing to Day 43 | 
| Occurrence of anti-somapacitan antibodies | Count | From Day 0 to Day 43 |