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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03905850
Recruitment Status : Completed
First Posted : April 5, 2019
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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

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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


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)




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



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03905850


Locations
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Germany
Novo Nordisk Investigational Site
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
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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    Key Record Dates
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

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