Dose Study in Healthy Males Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083 Compared to Norditropin® SimpleXx®
NCT ID: NCT01034202
Last Updated: 2017-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
56 participants
INTERVENTIONAL
2007-08-31
2008-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Norditropin® SimpleXx® 0.02 mg/kg + NNC126-0083
NNC126-0083
One of five dose levels administered subcutaneously (under the skin)
Norditropin® SimpleXx®
One of two dose levels, followed by NNC126-0083, administered subcutaneously (under the skin)
Norditropin® SimpleXx® 0.04 mg/kg + NNC126-0083
NNC126-0083
One of five dose levels administered subcutaneously (under the skin)
Norditropin® SimpleXx®
One of two dose levels, followed by NNC126-0083, administered subcutaneously (under the skin)
Norditropin® SimpleXx® 0.02 mg/kg + placebo
placebo
Placebo comparator
Norditropin® SimpleXx®
One of two dose levels, followed by placebo, administered subcutaneously (under the skin)
Norditropin® SimpleXx® 0.04 mg/kg + placebo
placebo
Placebo comparator
Norditropin® SimpleXx®
One of two dose levels, followed by placebo, administered subcutaneously (under the skin)
NNC126-0083
NNC126-0083
One of three dose levels administered subcutaneously (under the skin)
Placebo
placebo
Placebo comparator
Interventions
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NNC126-0083
One of five dose levels administered subcutaneously (under the skin)
Norditropin® SimpleXx®
One of two dose levels, followed by NNC126-0083, administered subcutaneously (under the skin)
placebo
Placebo comparator
NNC126-0083
One of three dose levels administered subcutaneously (under the skin)
Norditropin® SimpleXx®
One of two dose levels, followed by placebo, administered subcutaneously (under the skin)
Eligibility Criteria
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Inclusion Criteria
* Body Mass Index (BMI) between 19.0 and 28.0 kg/m2, both inclusive
* Body weight max. 100 kg
Exclusion Criteria
* 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
20 Years
40 Years
MALE
Yes
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Hvidovre, , Denmark
Countries
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References
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Rasmussen MH, Bysted BV, Anderson TW, Klitgaard T, Madsen J. Pegylated long-acting human growth hormone is well-tolerated in healthy subjects and possesses a potential once-weekly pharmacokinetic and pharmacodynamic treatment profile. J Clin Endocrinol Metab. 2010 Jul;95(7):3411-7. doi: 10.1210/jc.2009-2813. Epub 2010 Apr 28.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2007-001255-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN8630-1822
Identifier Type: -
Identifier Source: org_study_id
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