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

Status

Completed

Phase

Phase 1

Enrollment

33 participants (actual)

Sponsor

Novo Nordisk A/S · Industry

Design

Randomized · Quadruple masking

Countries

1 country

Germany

Start

29 Mar 2019

Primary completion

15 Jul 2019

Completion

15 Jul 2019

First posted

5 Apr 2019

Last update posted

6 Aug 2019

Conditions

Healthy Volunteers · Growth Hormone Deficiency

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.

• 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.

• 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.

• 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.

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

   Registry description

   ng\*h/mL

2. Maximum serum concentration of somapacitan

   Time frame · 0 to 504 hours after trial product administration

   Registry description

   ng/mL