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

Phase 1

Completed

• Conditions: Healthy; Growth Hormone Disorder
• Interventions: Drug: placebo; Drug: NNC126-0083; Drug: Norditropin® SimpleXx®

• Registration Number: NCT01034202
• Lead Sponsor: Novo Nordisk A/S

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Study First Submitted: 2009-12-16
• Study First Submitted QC: 2009-12-16
• Study First Posted: 2009-12-17
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-08
• Last Update Posted: 2017-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Norditropin® SimpleXx® 0.04 mg/kg + placebo	Norditropin® SimpleXx®	-
Norditropin® SimpleXx® 0.02 mg/kg + placebo	placebo	-
Placebo	placebo	-
Norditropin® SimpleXx® 0.02 mg/kg + NNC126-0083	Norditropin® SimpleXx®	-
Norditropin® SimpleXx® 0.04 mg/kg + NNC126-0083	Norditropin® SimpleXx®	-
Norditropin® SimpleXx® 0.04 mg/kg + placebo	placebo	-
Norditropin® SimpleXx® 0.02 mg/kg + placebo	Norditropin® SimpleXx®	-
Norditropin® SimpleXx® 0.02 mg/kg + NNC126-0083	NNC126-0083	-
Norditropin® SimpleXx® 0.04 mg/kg + NNC126-0083	NNC126-0083	-
NNC126-0083	NNC126-0083	-

Primary Outcome Measures

Name	Time	Method
Number of adverse events	after administration of a single dose of NNC126-0083

Secondary Outcome Measures

Name	Time	Method
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®

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇰 Hvidovre, Denmark