Status:
COMPLETED
Dose Study in Healthy Japanese Males Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Growth Hormone Disorder
Healthy
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of a NNC126-0083 in healthy male Japanese subjects.
Eligibility Criteria
Inclusion
- Healthy male subjects with Japanese passport and Japanese born parents
- Body Mass Index (BMI, kg/m2) between 18.0 and 27.0, both inclusive
- Subjects must be in good health according to age
Exclusion
- A history or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major diseases
- History of any illnesses or disease that, in the opinion of the Investigator might confound the results of the trial or pose additional risk in administering the trial product to the subject
- Any clinically significant abnormal haematology, biochemistry or urinalysis screening tests, as judged by the Investigator
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00722540
Start Date
July 1 2008
End Date
April 1 2009
Last Update
February 8 2017
Active Locations (1)
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1
Novo Nordisk Investigational Site
Neuss, Germany, 41460