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

Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Growth Hormone Disorder; Healthy

Intervention: NNC126-0083 (Drug); Norditropin® SimpleXx® (Drug); placebo (Drug); NNC126-0083 (Drug); Norditropin® SimpleXx® (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Novo Nordisk A/S

Official(s) and/or principal investigator(s):
Britta V. Bysted, Study Director, Affiliation: Novo Nordisk A/S

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Number of adverse events

Secondary outcome:

Area under the curve (AUC) (0-168h) after a single dose of NNC 126-0083

Number of injection site reactions

IGF-I (Insulin-like Growth Factor I) levels

Eligibility

Minimum age: 20 Years. Maximum age: 40 Years. Gender(s): Male.

Criteria:

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

Locations and Contacts

Hvidovre 2650, Denmark
Additional Information

Clinical Trials at Novo Nordisk

Starting date: August 2007
Last updated: July 24, 2012

Page last updated: August 23, 2015

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