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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy; Growth Hormone Disorder
• Intervention / Treatment: Drug: placebo; Drug: NNC126-0083; Drug: Norditropin® SimpleXx®; Drug: NNC126-0083; Drug: Norditropin® SimpleXx®

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 1

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre, Denmark, 2650
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: placebo; Placebo comparator
Experimental: NNC126-0083	Drug: NNC126-0083; One of five dose levels administered subcutaneously (under the skin); Drug: NNC126-0083; One of three dose levels administered subcutaneously (under the skin)
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); Drug: NNC126-0083; One of three dose levels administered subcutaneously (under the skin); Drug: Norditropin® SimpleXx®; One of two dose levels, followed by placebo, 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); Drug: NNC126-0083; One of three dose levels administered subcutaneously (under the skin); Drug: Norditropin® SimpleXx®; One of two dose levels, followed by placebo, 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 NNC126-0083, administered subcutaneously (under the skin); 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 NNC126-0083, administered subcutaneously (under the skin); Drug: Norditropin® SimpleXx®; One of two dose levels, followed by placebo, administered subcutaneously (under the skin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of adverse events	after administration of a single dose of NNC126-0083

Secondary Outcome Measures

Outcome Measure	Time Frame
Area under the curve (AUC) (0-168h) after a single dose of NNC 126-0083	0-168 hours after trial drug administration
Number of injection site reactions	after administration of a single dose of NNC126-0083 and after single dose of Norditropin® SimpleXx®
IGF-I (Insulin-like Growth Factor I) levels	after ascending single doses of NNC126-0083 and a single dose of Norditropin® SimpleXx®

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

General 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.

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: December 16, 2009
• First Submitted That Met QC Criteria: December 16, 2009
• First Posted (Estimate): December 17, 2009

Study Record Updates

• Last Update Posted (Estimate): February 9, 2017
• Last Update Submitted That Met QC Criteria: February 8, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: NN8630-1822; 2007-001255-19 (EudraCT Number)