DRUG
somapacitan
5 mg/1.5 ml and 10 mg/1.5 ml doses administered s.c. (subcutaneously, under the skin)
A Study to Compare the Uptake Into the Blood of Two Strengths of Somapacitan After Injection Under the Skin in Healthy Subjects
Status
Completed
Phase
Phase 1
Enrollment
33
Locations
1
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Apr 5, 2019
Study start
Mar 29, 2019
Primary completion
Jul 15, 2019
Study completion
Jul 15, 2019
Results posted
Not reported
Registry updated
Aug 6, 2019
Outcomes
What the study measures.
Primary outcomes
Area under the somapacitan serum concentration time curve from time 0 to the time of the last quantifiable concentration after dosing
Time frame · 0 to 504 hours after trial product administration
ng\*h/mL
Maximum serum concentration of somapacitan
Time frame · 0 to 504 hours after trial product administration
ng/mL
Secondary outcomes
Area under the somapacitan serum concentration time curve from time 0 to 168 hours after dosing
Time frame · 0 to 168 hours after trial product administration
ng\*h/mL
Area under the somapacitan serum concentration time curve from time 0 to infinity
Time frame · 0 to 504 hours after trial product administration
ng\*h/mL
Time to maximum serum concentration of somapacitan
Time frame · 0 to 504 hours after trial product administration
Hours
Terminal half-life of somapacitan
Time frame · 0 to 504 hours after trial product administration
Hours
Area under the insulin-like growth factor I (IGF-I) serum concentration time curve from time 0 to 168 hours after dosing
Time frame · 0 to 168 hours after trial product administration
ng\*h/mL
Maximum serum concentration of IGF-I after dosing
Time frame · 0 to 504 hours after trial product administration
ng/mL
Time to maximum serum concentration of IGF-I after dosing
Time frame · 0 to 504 hours after trial product administration
Hours
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 45 Years
- Sex
- ALL
- Healthy volunteers
- Yes
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.
Study locations
1 registered sites.
Germany. Showing up to 24 locations stored in the fast local snapshot.
Novo Nordisk Investigational Site
Neuss, Germany
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Related PeptideStat pages
Put the record in context.
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