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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Page 1 of 1 (1 locations)

1

Novo Nordisk Investigational Site

Neuss, Germany, 41460