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

NCT ID: NCT03905850

Last Updated: 2019-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-29
• Study Completion Date: 2019-07-15

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.

Conditions

Healthy Volunteers; Growth Hormone Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Somapacitan 5/10/10 mg

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.

Group Type: EXPERIMENTAL

somapacitan

Intervention Type: DRUG

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

Somapacitan 10/5/10 mg

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.

Group Type: EXPERIMENTAL

somapacitan

Intervention Type: DRUG

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

Somapacitan 10/10/5 mg

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.

Group Type: EXPERIMENTAL

somapacitan

Intervention Type: DRUG

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

Interventions

somapacitan

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Reporting Anchor and Disclosure (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Neuss, , Germany

Countries

Germany

References

Dombernowsky SL, Damholt BB, Hojby Rasmussen M, Svaerke C, Kildemoes RJ. Investigating the Bioavailability and Insulin-like Growth Factor-I Release of Two Different Strengths of Somapacitan: A Randomised, Double-Blind Crossover Trial. Clin Pharmacokinet. 2024 Jul;63(7):1015-1024. doi: 10.1007/s40262-024-01395-y. Epub 2024 Jul 5.

Reference Type: DERIVED

PMID: 38969919 (View on PubMed)

Other Identifiers

2018-003670-27

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1220-5197

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN8640-4491

Identifier Type: -

Identifier Source: org_study_id