Status:
COMPLETED
First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Growth Hormone Disorder
Adult Growth Hormone Deficiency
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
This trial is conducted in Europe. The aim of this trial is to assess safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the invest...
Eligibility Criteria
Inclusion
- Healthy, non-smoking male subjects
- BMI (body mass index) between 18.0 and 28.0 kg/m\^2, both incl.
- Body weight 50 to 100 kg, both incl.
Exclusion
- Strenuous exercise within 4 days prior to dosing
- Receipt of any investigational medicinal product within 3 months prior to randomisation
Key Trial Info
Start Date :
January 16 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2013
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT01514500
Start Date
January 16 2012
End Date
March 18 2013
Last Update
December 24 2020
Active Locations (1)
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1
Novo Nordisk Investigational Site
Neuss, Germany, 41460