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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; Growth Hormone Deficiency
• Intervention / Treatment: Drug: somapacitan

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Neuss, Germany, 41460
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: somapacitan; 5 mg/1.5 ml and 10 mg/1.5 ml doses administered s.c. (subcutaneously, under the skin)
EXPERIMENTAL: 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.	Drug: somapacitan; 5 mg/1.5 ml and 10 mg/1.5 ml doses administered s.c. (subcutaneously, under the skin)
EXPERIMENTAL: 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.	Drug: somapacitan; 5 mg/1.5 ml and 10 mg/1.5 ml doses administered s.c. (subcutaneously, under the skin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Maximum serum concentration of somapacitan	ng/mL	0 to 504 hours after trial product administration

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 29, 2019
• Primary Completion (ACTUAL): July 15, 2019
• Study Completion (ACTUAL): July 15, 2019

Study Registration Dates

• First Submitted: April 3, 2019
• First Submitted That Met QC Criteria: April 3, 2019
• First Posted (ACTUAL): April 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 6, 2019
• Last Update Submitted That Met QC Criteria: August 5, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: NN8640-4491; 2018-003670-27 (REGISTRY: European Medicines Agency (EudraCT)); U1111-1220-5197 (REGISTRY: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No