NCT00931476CompletedPhase 1
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)
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Treatment Emergent Adverse Events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 50 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Treatment Emergent Adverse Events
Time Frame: from 0 to 24 hours following injection
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
Secondary Outcomes
- Area under the hGH concentration-time curve GH AUC0-∞)
- Elimination half-life (GH t½)
- Non-treatment Emergent Adverse Events
- Time to maximum hGH concentration (GH tmax)
- Growth Factors (IGF-I and IGFBP-3)
Investigators
Study Sites (1)
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