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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01034202
• Other study ID #: NN8630-1822
• Secondary ID: 2007-001255-19
• Status: Completed
• Phase: Phase 1
• First received: December 16, 2009
• Last updated: February 8, 2017
• Start date: August 2007
• Est. completion date: January 2008

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Growth Hormone Disorder
• Healthy

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
Denmark	Novo Nordisk Investigational Site	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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 Me — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events		after administration of a single dose of NNC126-0083
Secondary	Area under the curve (AUC) (0-168h) after a single dose of NNC 126-0083		0-168 hours after trial drug administration
Secondary	Number of injection site reactions		after administration of a single dose of NNC126-0083 and after single dose of Norditropin® SimpleXx®
Secondary	IGF-I (Insulin-like Growth Factor I) levels		after ascending single doses of NNC126-0083 and a single dose of Norditropin® SimpleXx®

External Links

•   Clinical Trials at Novo Nordisk