Dose Study in Healthy Japanese Males Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083
- Registration Number
- NCT00722540
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 40
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A NNC126-0083 - A placebo - B NNC126-0083 - B placebo - C placebo - D placebo - E placebo - C NNC126-0083 - E NNC126-0083 - D NNC126-0083 -
- Primary Outcome Measures
Name Time Method Safety and tolerability (adverse events, local tolerability, physical examination) 0 to 10 days after third dosing, (day 15-25 after first dose)
- Secondary Outcome Measures
Name Time Method Cmax, maximum concentration of IGF-I 7 days after first dosing and 10 days after the third dosing (day 1-25 after first dose)
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇩🇪Neuss, Germany