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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Growth Hormone Disorder

Treatments: Drug: Norditropin® SimpleXx®; Drug: NNC126-0083; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01034202

NN8630-1822

2007-001255-19 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 56 patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 6 patient groups, including a placebo group

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

Experimental group

Treatment:

Drug: Norditropin® SimpleXx®

Drug: NNC126-0083

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

Experimental group

Treatment:

Drug: Norditropin® SimpleXx®

Drug: NNC126-0083

Norditropin® SimpleXx® 0.02 mg/kg + placebo

Placebo Comparator group

Treatment:

Drug: placebo

Drug: Norditropin® SimpleXx®

Norditropin® SimpleXx® 0.04 mg/kg + placebo

Placebo Comparator group

Treatment:

Drug: placebo

Drug: Norditropin® SimpleXx®

NNC126-0083

Experimental group

Treatment:

Drug: NNC126-0083

Placebo

Placebo Comparator group

Treatment:

Drug: placebo