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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:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00931476
First received: June 30, 2009
Last updated: February 23, 2017
Last verified: February 2017
  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: 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

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
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 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
Study First Received: June 30, 2009
Last Updated: February 23, 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

ClinicalTrials.gov processed this record on June 23, 2017