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

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.
 
ClinicalTrials.gov Identifier: NCT00931476
Recruitment Status : Completed
First Posted : July 2, 2009
Last Update Posted : February 27, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE June 30, 2009
First Posted Date  ICMJE July 2, 2009
Last Update Posted Date February 27, 2017
Actual Study Start Date  ICMJE April 6, 2000
Actual Primary Completion Date June 8, 2000   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2009)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2009)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Single Dose Trial in Healthy Caucasians and Japanese Subjects Investigating the Pharmacokinetics of Somatropin
Official Title  ICMJE 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)
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Growth Hormone Disorder
  • Adult Growth Hormone Deficiency
  • Healthy
Intervention  ICMJE
  • Drug: somatropin
  • Drug: placebo
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 30, 2009)
86
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 8, 2000
Actual Primary Completion Date June 8, 2000   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00931476
Other Study ID Numbers  ICMJE GHKIN-1253
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP