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

Novo Nordisk logo

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

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems