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

• ClinicalTrials.gov Identifier: NCT03905850
• Recruitment Status: Completed
• First Posted: April 5, 2019
• Last Update Posted: August 6, 2019
• Sponsor: Novo Nordisk A/S
• Information provided by (Responsible Party): Novo Nordisk A/S

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy Volunteers; Growth Hormone Deficiency	Drug: somapacitan	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: March 29, 2019
• Actual Primary Completion Date: July 15, 2019
• Actual Study Completion Date: July 15, 2019

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Germany

Novo Nordisk Investigational Site

Neuss, Germany, 41460

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

• Study Director: Clinical Reporting Anchor and Disclosure (1452); Novo Nordisk A/S

More Information

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT03905850
• Other Study ID Numbers: NN8640-4491; 2018-003670-27 ( Registry Identifier: European Medicines Agency (EudraCT) ); U1111-1220-5197 ( Registry Identifier: World Health Organization (WHO) )
• First Posted: April 5, 2019
• Last Update Posted: August 6, 2019
• Last Verified: August 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
• URL: http://novonordisk-trials.com

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No