Brief Title
A Study to Compare the Uptake Into the Blood of Two Strengths of Somapacitan After Injection Under the Skin in Healthy Subjects
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
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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Area under the somapacitan serum concentration time curve from time 0 to the time of the last quantifiable concentration after dosing
Secondary Outcome
Area under the somapacitan serum concentration time curve from time 0 to 168 hours after dosing
Condition
Healthy Volunteers
Intervention
somapacitan
Study Arms / Comparison Groups
Somapacitan 5/10/10 mg
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
33
Start Date
March 29, 2019
Completion Date
July 15, 2019
Primary Completion Date
July 15, 2019
Eligibility 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.
Gender
All
Ages
18 Years - 45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Clinical Reporting Anchor and Disclosure (1452), ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT03905850
Organization ID
NN8640-4491
Secondary IDs
2018-003670-27
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
Clinical Reporting Anchor and Disclosure (1452), Study Director, Novo Nordisk A/S
Verification Date
August 2019