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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers; Growth Hormone Deficiency

Treatments: Drug: somapacitan

Study type: Interventional

Funder types: Industry

Identifiers

NCT03905850

U1111-1220-5197 (Registry Identifier)

2018-003670-27 (Registry Identifier)

NN8640-4491

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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33 participants in 3 patient groups

Somapacitan 5/10/10 mg

Experimental group

Description:

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.

Treatment:

Drug: somapacitan

Somapacitan 10/5/10 mg

Experimental group

Description:

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.

Treatment:

Drug: somapacitan

Somapacitan 10/10/5 mg

Experimental group

Description:

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.

Treatment:

Drug: somapacitan