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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT00931476 |
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Date of registration:
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30/06/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Single Dose Trial in Healthy Caucasians and Japanese Subjects Investigating the Pharmacokinetics of Somatropin
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Scientific title:
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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) |
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Date of first enrolment:
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April 6, 2000 |
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Target sample size:
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86 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00931476 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Global Clinical Registry (GCR, 1452) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novo Nordisk A/S |
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Key inclusion & exclusion criteria
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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
Age minimum:
20 Years
Age maximum:
50 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Growth Hormone Disorder
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Healthy
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Adult Growth Hormone Deficiency
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Intervention(s)
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Drug: placebo
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Drug: somatropin
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Primary Outcome(s)
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Treatment Emergent Adverse Events
[Time Frame: from 0 to 24 hours following injection]
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Area under the hGH concentration-time curve (GH AUC0-24h)
[Time Frame: from 0 to 24 hours following injection]
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Maximum hGH concentration (GH Cmax)
[Time Frame: from 0 to 24 hours following injection]
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Secondary Outcome(s)
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Area under the hGH concentration-time curve GH AUC0-8)
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Elimination half-life (GH t½)
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Non-treatment Emergent Adverse Events
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Growth Factors (IGF-I and IGFBP-3)
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Time to maximum hGH concentration (GH tmax)
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Secondary ID(s)
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GHKIN-1253
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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