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A Single Dose Trial in Healthy Caucasians and Japanese Subjects Investigating the Pharmacokinetics of Somatropin

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00931476
First Posted: July 2, 2009
Last Update Posted: February 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
This trial was conducted in the United States of America (USA). The aim of this clinical trial was to investigate the pharmacokinetics of somatropin in healthy Japanese and Caucasian subjects, and to identify somatostatin-related adverse events.

Condition Intervention Phase
Growth Hormone Disorder Adult Growth Hormone Deficiency Healthy Drug: somatropin Drug: placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Single-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group, Single Dose Trial in Healthy Caucasians and Japanese Subjects Investigating the Pharmacokinetics of Norditropin® (Norditropin® PenSet® 24)

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Area under the hGH concentration-time curve (GH AUC0-24h) [ Time Frame: from 0 to 24 hours following injection ]
  • Maximum hGH concentration (GH Cmax) [ Time Frame: from 0 to 24 hours following injection ]
  • Treatment Emergent Adverse Events [ Time Frame: from 0 to 24 hours following injection ]

Secondary Outcome Measures:
  • Time to maximum hGH concentration (GH tmax)
  • Area under the hGH concentration-time curve GH AUC0-∞)
  • Elimination half-life (GH t½)
  • Growth Factors (IGF-I and IGFBP-3)
  • Non-treatment Emergent Adverse Events

Enrollment: 86
Actual Study Start Date: April 6, 2000
Study Completion Date: June 8, 2000
Primary Completion Date: June 8, 2000 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Signed informed consent before any trial related activities
  • Japanese and Caucasian males respectively
  • Healthy subjects based upon medical history, physical examination, vital signs, ECG, serum biochemistry and haematology and urinalysis
  • Body Mass Index (BMI) between 17 and 30 m2/kg, inclusive
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00931476


Locations
United States, Hawaii
Novo Nordisk Investigational Site
Honolulu, Hawaii, United States, 96814-4224
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00931476     History of Changes
Other Study ID Numbers: GHKIN-1253
First Submitted: June 30, 2009
First Posted: July 2, 2009
Last Update Posted: February 27, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Dwarfism, Pituitary
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases