Clinical trial NCT01034202: Dose Study in Healthy Males Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083 Compared to Norditropin® SimpleXx®
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Growth Hormone Disorder
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-12-17
Enrollment: 56
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Number of adverse events
timeFrame: after administration of a single dose of NNC126-0083
Secondary outcomes:
measure: Area under the curve (AUC) (0-168h) after a single dose of NNC 126-0083
timeFrame: 0-168 hours after trial drug administration
measure: Number of injection site reactions
timeFrame: after administration of a single dose of NNC126-0083 and after single dose of Norditropin® SimpleXx®
measure: IGF-I (Insulin-like Growth Factor I) levels
timeFrame: after ascending single doses of NNC126-0083 and a single dose of Norditropin® SimpleXx®
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: 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.