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CompletedNCT01034202Updated Feb 9, 2017

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

A Phase 1 interventional study of NNC126-0083 and Norditropin® SimpleXx® in Growth Hormone Disorder and Healthy, sponsored by Novo Nordisk A/S. Completed at 1 site in Denmark. Open to male participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-09.

Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Male
01

Study 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

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Conditions studied

  • Growth Hormone Disorder
  • Healthy
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In context

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
56 participants (actual)

Study arms

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

    Drug: NNC126-0083 · Drug: Norditropin® SimpleXx®

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

    Drug: NNC126-0083 · Drug: Norditropin® SimpleXx®

  • Placebo comparator
    Norditropin® SimpleXx® 0.02 mg/kg + placebo

    Drug: placebo · Drug: Norditropin® SimpleXx®

  • Placebo comparator
    Norditropin® SimpleXx® 0.04 mg/kg + placebo

    Drug: placebo · Drug: Norditropin® SimpleXx®

  • Experimental
    NNC126-0083

    Drug: NNC126-0083

  • Placebo comparator
    Placebo

    Drug: placebo

Interventions

  • DrugNNC126-0083

    One of five dose levels administered subcutaneously (under the skin)

  • DrugNorditropin® SimpleXx®

    One of two dose levels, followed by NNC126-0083, administered subcutaneously (under the skin)

  • Drugplacebo

    Placebo comparator

  • DrugNNC126-0083

    One of three dose levels administered subcutaneously (under the skin)

  • DrugNorditropin® SimpleXx®

    One of two dose levels, followed by placebo, administered subcutaneously (under the skin)

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What researchers measure

Primary outcomes

  1. Number of adverse events

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

Secondary outcomes

  1. Area under the curve (AUC) (0-168h) after a single dose of NNC 126-0083

    Time frame: 0-168 hours after trial drug administration

  2. Number of injection site reactions

    Time frame: after administration of a single dose of NNC126-0083 and after single dose of Norditropin® SimpleXx®

  3. IGF-I (Insulin-like Growth Factor I) levels

    Time frame: after ascending single doses of NNC126-0083 and a single dose of Norditropin® SimpleXx®

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Study locations

1 site
  • Novo Nordisk Investigational Site
    Hvidovre, 2650, Denmark
08

References and documents

Publications

  • 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. PubMed 20427496 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01034202
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Dec 17, 2009
Start date
Aug 2007
Primary completion
Jan 2008
Completion
Jan 2008
Last update
Feb 9, 2017

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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