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NCT Number: NCT03905850

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

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.

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Key information

Conditions

Healthy Volunteers Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Growth Hormone Deficiency Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Somapacitan

Drug

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

Primary outcomes

  1. Area under the somapacitan serum concentration time curve from time 0 to the time of the last quantifiable concentration after dosing

    Time frame: 0 to 504 hours after trial product administration

    ng*h/mL

  2. Maximum serum concentration of somapacitan

    Time frame: 0 to 504 hours after trial product administration

    ng/mL

Secondary outcomes

  1. Area under the somapacitan serum concentration time curve from time 0 to 168 hours after dosing

    Time frame: 0 to 168 hours after trial product administration

    ng*h/mL

  2. Area under the somapacitan serum concentration time curve from time 0 to infinity

    Time frame: 0 to 504 hours after trial product administration

    ng*h/mL

  3. Time to maximum serum concentration of somapacitan

    Time frame: 0 to 504 hours after trial product administration

    Hours

  4. Terminal half-life of somapacitan

    Time frame: 0 to 504 hours after trial product administration

    Hours

  5. Area under the insulin-like growth factor I (IGF-I) serum concentration time curve from time 0 to 168 hours after dosing

    Time frame: 0 to 168 hours after trial product administration

    ng*h/mL

  6. Maximum serum concentration of IGF-I after dosing

    Time frame: 0 to 504 hours after trial product administration

    ng/mL

  7. Time to maximum serum concentration of IGF-I after dosing

    Time frame: 0 to 504 hours after trial product administration

    Hours

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 5, 2019
Registry last updated
Aug 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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