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

Healthy Volunteers Clinical Trial

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

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
• 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
• 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.

Related Conditions & MeSH terms

• Dwarfism, Pituitary
• Growth Hormone Deficiency
• Healthy Volunteers

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