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Clinical Trials/NCT01034202
NCT01034202
Completed
Phase 1

A Randomised, Double Blind, Placebo-controlled, Single Dose, Dose-escalating Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pegylated Long-acting Human Growth Hormone (NNC126-0083) Compared to Norditropin® SimpleXx® in Healthy Male Subjects

Novo Nordisk A/S1 site in 1 country56 target enrollmentAugust 2007
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ConditionsGrowth Hormone DisorderHealthy
InterventionsplaceboNNC126-0083Norditropin® SimpleXx®
DrugsNNC126-0083Norditropin® SimpleXx®placebo

Overview

Phase
Phase 1
Intervention
placebo
Conditions
Growth Hormone Disorder
Sponsor
Novo Nordisk A/S
Enrollment
56
Locations
1
Primary Endpoint
Number of adverse events
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief 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

Registry
clinicaltrials.gov
Start Date
August 2007
End Date
January 2008
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility 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

Arms & Interventions

Norditropin® SimpleXx® 0.02 mg/kg + placebo

Intervention: placebo

Norditropin® SimpleXx® 0.02 mg/kg + NNC126-0083

Intervention: NNC126-0083

Norditropin® SimpleXx® 0.02 mg/kg + NNC126-0083

Intervention: Norditropin® SimpleXx®

Norditropin® SimpleXx® 0.04 mg/kg + NNC126-0083

Intervention: NNC126-0083

Norditropin® SimpleXx® 0.04 mg/kg + NNC126-0083

Intervention: Norditropin® SimpleXx®

Norditropin® SimpleXx® 0.02 mg/kg + placebo

Intervention: Norditropin® SimpleXx®

Norditropin® SimpleXx® 0.04 mg/kg + placebo

Intervention: placebo

Norditropin® SimpleXx® 0.04 mg/kg + placebo

Intervention: Norditropin® SimpleXx®

NNC126-0083

Intervention: NNC126-0083

Placebo

Intervention: placebo

Outcomes

Primary Outcomes

Number of adverse events

Time Frame: after administration of a single dose of NNC126-0083

Secondary Outcomes

  • Area under the curve (AUC) (0-168h) after a single dose of NNC 126-0083(0-168 hours after trial drug administration)
  • Number of injection site reactions(after administration of a single dose of NNC126-0083 and after single dose of Norditropin® SimpleXx®)
  • IGF-I (Insulin-like Growth Factor I) levels(after ascending single doses of NNC126-0083 and a single dose of Norditropin® SimpleXx®)

Study Sites (1)

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