Dose Study in Healthy Males Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083 Compared to Norditropin® SimpleXx®

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (exposure of drug) and pharmacodynamics (effect) of NNC126-0083 compared to Norditropin® SimpleXx® and placebo in healthy volunteers

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novo Nordisk A/S

Criteria

Inclusion Criteria:

• Healthy, non-smoking male subjects

• Body Mass Index (BMI) between 19.0 and 28.0 kg/m2, both inclusive

• Body weight max. 100 kg

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

• Carrier of Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies

• Positive result of test for HIV (Human Immunodeficiency Virus) antibodies

• Any clinically significant abnormal haematology or biochemistry screening tests, as judged by the physician

• Clinically significant abnormal ECG (ElectroCardioGram) at screening as evaluated by the physician

• A significant history of alcoholism or drug/chemical abuse, or who has a positive result in the urine drug/alcohol screen, or who consumes more than 28 units of alcohol per week (one unit of alcohol equals about 250 ml of beer or lager, 1 glass of wine, or 20 ml of spirits)

• Habitual smoking, i.e daily smoking or more than 7 cigarettes/week

• Mental incapacity or language barriers which preclude adequate understanding or cooperation, who are unwilling to participate in the trial, or who in the opinion of their general practitioner or the Investigator should not participate in the trial

• Surgery or trauma with significant blood loss within the last 2 months prior to dosing