A Study to Compare the Uptake Into the Blood of Two Strengths of Somapacitan After Injection Under the Skin in Healthy Subjects

Study Overview
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Brief Summary
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This study will compare two strengths of the new long-acting growth hormone somapacitan. The aim of this study is to test if both strengths are taken up in the blood in the same way. During three separate dosing visits participants will get a total of 3 injections of the study medicine. Somapacitan is not yet approved and therefore cannot be prescribed by a doctor outside of this study. The study duration is between 10 and 15 weeks. Participants will have 17 visits with the study doctor. Three visits will each comprise 6 in-house days with overnight stays. In total, at least 15 overnight stays at the clinic. There will be blood samplings during the study. Participants must come to the clinic regularly for these blood samplings. People who have already received growth hormones in the past or who are growth hormone deficient cannot be in the study. People cannot be in the study if the study doctor thinks that there are risks for their health. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

Official Title
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A Randomised, Double-blind, Single Dose, Three Period, Complete Cross Over Trial in Healthy Subjects Investigating the Pharmacokinetics of Subcutaneous Injections of Somapacitan 5 mg/1.5 mL and 10 mg/1.5 mL

Conditions
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Healthy Volunteers, Growth Hormone Deficiency

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 18-45 years (both inclusive) at the time of signing informed consent. Body mass index (BMI) between 18.5 and 24.9 kg/m^2 (both inclusive). Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator. Exclusion Criteria: Participation in any clinical trial of an approved or non-approved investigational medicinal product within 45 days or 5 times the half-life of the previous investigational medicinal product, whichever is longer, before screening. Body weight above 100.0 kg Subject with any known history of growth hormone deficiency as declared by the subject. Subject who is non-naïve to growth hormone treatment as declared by the subject.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Somapacitan 5/10/10 mg<br>One dose of somapacitan 5 mg/1.5 ml followed by two doses of somapacitan 10 mg/1.5 ml. Each dose will be followed by a 3 week observation period. | Drug: somapacitan<br>* 5 mg/1.5 ml and 10 mg/1.5 ml doses administered s.c. (subcutaneously, under the skin)<br>|
| Experimental: Somapacitan 10/5/10 mg<br>One dose of somapacitan 10 mg/1.5 ml followed by a 5 mg/1.5 ml dose followed by a 10 mg/1.5 ml dose. Each dose will be followed by a 3 week observation period. | Drug: somapacitan<br>* 5 mg/1.5 ml and 10 mg/1.5 ml doses administered s.c. (subcutaneously, under the skin)<br>|
| Experimental: Somapacitan 10/10/5 mg<br>Two doses of 10 mg/1.5 ml somapacitan followed by a 5 mg/1.5 ml dose. Each dose will be followed by a 3 week observation period. | Drug: somapacitan<br>* 5 mg/1.5 ml and 10 mg/1.5 ml doses administered s.c. (subcutaneously, under the skin)<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 from time 0 to the time of the last quantifiable concentration after dosing | ng*h/mL | 0 to 504 hours after trial product administration | 
| Maximum serum concentration of somapacitan | ng/mL | 0 to 504 hours after trial product administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the somapacitan serum concentration time curve from time 0 to 168 hours after dosing | ng*h/mL | 0 to 168 hours after trial product administration | 
| Area under the somapacitan serum concentration time curve from time 0 to infinity | ng*h/mL | 0 to 504 hours after trial product administration | 
| Time to maximum serum concentration of somapacitan | Hours | 0 to 504 hours after trial product administration | 
| Terminal half-life of somapacitan | Hours | 0 to 504 hours after trial product administration | 
| Area under the insulin-like growth factor I (IGF-I) serum concentration time curve from time 0 to 168 hours after dosing | ng*h/mL | 0 to 168 hours after trial product administration | 
| Maximum serum concentration of IGF-I after dosing | ng/mL | 0 to 504 hours after trial product administration | 
| Time to maximum serum concentration of IGF-I after dosing | Hours | 0 to 504 hours after trial product administration |