Clinical trial NCT03905850: A Study to Compare the Uptake Into the Blood of Two Strengths of Somapacitan After Injection Under the Skin in Healthy Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Growth Hormone Deficiency
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2019-04-05
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Area under the somapacitan serum concentration time curve from time 0 to the time of the last quantifiable concentration after dosing
timeFrame: 0 to 504 hours after trial product administration
measure: Maximum serum concentration of somapacitan
timeFrame: 0 to 504 hours after trial product administration
Secondary outcomes:
measure: Area under the somapacitan serum concentration time curve from time 0 to 168 hours after dosing
timeFrame: 0 to 168 hours after trial product administration
measure: Area under the somapacitan serum concentration time curve from time 0 to infinity
timeFrame: 0 to 504 hours after trial product administration
measure: Time to maximum serum concentration of somapacitan
timeFrame: 0 to 504 hours after trial product administration
measure: Terminal half-life of somapacitan
timeFrame: 0 to 504 hours after trial product administration
measure: Area under the insulin-like growth factor I (IGF-I) serum concentration time curve from time 0 to 168 hours after dosing
timeFrame: 0 to 168 hours after trial product administration
measure: Maximum serum concentration of IGF-I after dosing
timeFrame: 0 to 504 hours after trial product administration
measure: Time to maximum serum concentration of IGF-I after dosing
timeFrame: 0 to 504 hours after trial product administration
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References: