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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03905850
Other study ID # NN8640-4491
Secondary ID 2018-003670-27U1
Status Completed
Phase Phase 1
First received
Last updated
Start date March 29, 2019
Est. completion date July 15, 2019

Study information

Verified date August 2019
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date July 15, 2019
Est. primary completion date July 15, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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 Design


Intervention

Drug:
somapacitan
5 mg/1.5 ml and 10 mg/1.5 ml doses administered s.c. (subcutaneously, under the skin)

Locations

Country Name City State
Germany Novo Nordisk Investigational Site Neuss

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Maximum serum concentration of somapacitan ng/mL 0 to 504 hours after trial product administration
Secondary 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
Secondary Area under the somapacitan serum concentration time curve from time 0 to infinity ng*h/mL 0 to 504 hours after trial product administration
Secondary Time to maximum serum concentration of somapacitan Hours 0 to 504 hours after trial product administration
Secondary Terminal half-life of somapacitan Hours 0 to 504 hours after trial product administration
Secondary 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
Secondary Maximum serum concentration of IGF-I after dosing ng/mL 0 to 504 hours after trial product administration
Secondary Time to maximum serum concentration of IGF-I after dosing Hours 0 to 504 hours after trial product administration
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