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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01034202
First received: December 16, 2009
Last updated: July 24, 2012
Last verified: July 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Growth Hormone Disorder
Healthy
 Drug: NNC126-0083
Drug: Norditropin® SimpleXx®
Drug: placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Number of adverse events [ Time Frame: after administration of a single dose of NNC126-0083 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Area under the curve (AUC) (0-168h) after a single dose of NNC 126-0083 [ Time Frame: 0-168 hours after trial drug administration ] [ Designated as safety issue: No ]
  • Number of injection site reactions [ Time Frame: after administration of a single dose of NNC126-0083 and after single dose of Norditropin® SimpleXx® ] [ Designated as safety issue: Yes ]
  • IGF-I (Insulin-like Growth Factor I) levels [ Time Frame: after ascending single doses of NNC126-0083 and a single dose of Norditropin® SimpleXx® ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: August 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Norditropin® SimpleXx® 0.02 mg/kg + NNC126-0083 Drug: NNC126-0083
One of five dose levels administered subcutaneously (under the skin)
Drug: Norditropin® SimpleXx®
One of two dose levels, followed by NNC126-0083, administered subcutaneously (under the skin)
Experimental: Norditropin® SimpleXx® 0.04 mg/kg + NNC126-0083 Drug: NNC126-0083
One of five dose levels administered subcutaneously (under the skin)
Drug: Norditropin® SimpleXx®
One of two dose levels, followed by NNC126-0083, administered subcutaneously (under the skin)
Placebo Comparator: Norditropin® SimpleXx® 0.02 mg/kg + placebo Drug: placebo
Placebo comparator
Drug: Norditropin® SimpleXx®
One of two dose levels, followed by placebo, administered subcutaneously (under the skin)
Placebo Comparator: Norditropin® SimpleXx® 0.04 mg/kg + placebo Drug: placebo
Placebo comparator
Drug: Norditropin® SimpleXx®
One of two dose levels, followed by placebo, administered subcutaneously (under the skin)
Experimental: NNC126-0083 Drug: NNC126-0083
One of three dose levels administered subcutaneously (under the skin)
Placebo Comparator: Placebo Drug: placebo
Placebo comparator

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01034202

Locations
Denmark
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Britta V. Bysted Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided by Novo Nordisk

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01034202     History of Changes
Other Study ID Numbers: NN8630-1822, 2007-001255-19
Study First Received: December 16, 2009
Last Updated: July 24, 2012
Health Authority: Denmark: Danish Medicines Agency

ClinicalTrials.gov processed this record on May 19, 2013