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

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT03905850

Collaborator

(none)

Enrollment

Location

Arms

3.5

Actual Duration (Months)

9.3

Patients Per Site Per Month

Study Details

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

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 :

Mar 29, 2019

Actual Primary Completion Date :

Jul 15, 2019

Actual Study Completion Date :

Jul 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)

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

Area under the somapacitan serum concentration time curve from time 0 to the time of the last quantifiable concentration after dosing [0 to 504 hours after trial product administration]
ng*h/mL
Maximum serum concentration of somapacitan [0 to 504 hours after trial product administration]
ng/mL

Secondary Outcome Measures

Area under the somapacitan serum concentration time curve from time 0 to 168 hours after dosing [0 to 168 hours after trial product administration]
ng*h/mL
Area under the somapacitan serum concentration time curve from time 0 to infinity [0 to 504 hours after trial product administration]
ng*h/mL
Time to maximum serum concentration of somapacitan [0 to 504 hours after trial product administration]
Hours
Terminal half-life of somapacitan [0 to 504 hours after trial product administration]
Hours
Area under the insulin-like growth factor I (IGF-I) serum concentration time curve from time 0 to 168 hours after dosing [0 to 168 hours after trial product administration]
ng*h/mL
Maximum serum concentration of IGF-I after dosing [0 to 504 hours after trial product administration]
ng/mL
Time to maximum serum concentration of IGF-I after dosing [0 to 504 hours after trial product administration]
Hours

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT03905850

Other Study ID Numbers:

NN8640-4491
2018-003670-27
U1111-1220-5197

First Posted:

Apr 5, 2019

Last Update Posted:

Aug 6, 2019

Last Verified:

Aug 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 6, 2019