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

NCT01034202 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2017-02-09

No results posted yet for this study

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

Conditions

  • Growth Hormone Disorder
  • Healthy

Interventions

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

placebo

Placebo comparator

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)

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2008-01-31
Completion
2008-01-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01034202 on ClinicalTrials.gov