Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function

Study Overview
=================
Brief Summary
-----------------
The trial is conducted in Europe. The aim of the trial is to investigate the steady state exposure of somapacitan in subjects with various degrees of renal impairment (mild, moderate, severe renal impairment, requiring haemodialysis treatment) compared to subjects with normal renal function

Official Title
-----------------
Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function

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

Intervention / Treatment
-----------------
* Drug: Somapacitan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent Body mass index between 18.5-34.9 kg/sqm (both inclusive) Meeting the pre-defined glomerular filtration rate for any of the renal function groups 1-4 (based on the measured glomerular filtration rate using exogenous sinistrin (Inutest®) as a filtration marker) or being in treatment with haemodialysis 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). 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 disorder, except for conditions associated with renal impairment in the groups of subjects with reduced renal function, which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol. For example, arterial hypertension, anaemia, impaired glucose tolerance or type 2 diabetes are accepted in the group of subjects with renal impairment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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 renal function<br>Subjects with normal renal function | Drug: Somapacitan<br>* All subjects will receive three (0.08 mg/kg) consecutive once-weekly s.c. (under the skin) administrations of somapacitan<br>|
| Experimental: Mild renal impairment<br>Subjects with mild renal impairment | Drug: Somapacitan<br>* All subjects will receive three (0.08 mg/kg) consecutive once-weekly s.c. (under the skin) administrations of somapacitan<br>|
| Experimental: Moderate renal impairment<br>Subjects with moderate renal impairment | Drug: Somapacitan<br>* All subjects will receive three (0.08 mg/kg) consecutive once-weekly s.c. (under the skin) administrations of somapacitan<br>|
| Experimental: Severe renal impairment<br>Subjects with severe renal impairment | Drug: Somapacitan<br>* All subjects will receive three (0.08 mg/kg) consecutive once-weekly s.c. (under the skin) administrations of somapacitan<br>|
| Experimental: Requiring haemodialysis treatment<br>Subjects requiring haemodialysis treatment | Drug: Somapacitan<br>* All subjects will receive three (0.08 mg/kg) consecutive once-weekly s.c. (under the skin) administrations of somapacitan<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the somapacitan serum concentration time curve | Calculated based on the serum concentrations measured in ug/l | 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 | Measured in ng/ml | After the last dosing on Day 15 up until Day 43 | 
| Time to maximum serum concentration of somapacitan | Calculated based on the serum concentrations measured in ug/l | After the last dosing on Day 15 up until Day 43 | 
| Incidence of adverse events | Count and % of events | Day 0 - 43 | 
| Occurrence of anti-somapacitan antibodies | Count or % of events | Day 0 - 43 |