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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00931476
First received: June 30, 2009
Last updated: June 28, 2012
Last verified: June 2012
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
  • Maximum hGH concentration (GH Cmax) [ Time Frame: from 0 to 24 hours following injection ] [ Designated as safety issue: No ]
  • Treatment Emergent Adverse Events [ Time Frame: from 0 to 24 hours following injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to maximum hGH concentration (GH tmax) [ Designated as safety issue: No ]
  • Area under the hGH concentration-time curve GH AUC0-∞) [ Designated as safety issue: No ]
  • Elimination half-life (GH t½) [ Designated as safety issue: No ]
  • Growth Factors (IGF-I and IGFBP-3) [ Designated as safety issue: No ]
  • Non-treatment Emergent Adverse Events [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 50 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00931476

Locations
United States, Hawaii
Novo Nordisk Clinical Trial Call Center
Honolulu, Hawaii, United States, 96814-4224
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Michael Højby Rasmussen, MD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00931476     History of Changes
Other Study ID Numbers: GHKIN-1253
Study First Received: June 30, 2009
Last Updated: June 28, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 21, 2014