A Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth Hormone
Phase 2
Completed
- Conditions
- Growth Hormone DisorderGrowth Hormone Deficiency in Children
- Interventions
- Registration Number
- NCT00936403
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics (the determination of the concentration of the administered medication in blood over time) and pharmacodynamics (the determination of the effect over time and the duration of action) of a long-acting growth hormone (NNC126-0083) in growth hormone deficient children.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
Inclusion Criteria
- Confirmed diagnosis of growth hormone insufficiency as defined by two different GH provocation tests, defined as a peak of GH level less than 7ng/ml
- Pre-pubertal children
- Growth hormone replacement treatment for at least three months
Exclusion Criteria
- Evidence of tumour growth or malignant disease
- Growth hormone deficient children with overt diabetes mellitus (fasting blood glucose more than 126mg/dl)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description NNC126-0083 NNC126-0083 - Norditropin NordiFlex® somatropin -
- Primary Outcome Measures
Name Time Method Frequency of Adverse events (AEs) 0-10 days after dosing
- Secondary Outcome Measures
Name Time Method AUC (0-168h), the area under the plasma NNC126-0083 profile in the interval 0-168 hours after trial product administration Measured 10 days after dosing IGF-I AUC (0-168h) the area under IGF-I profile in the interval 0-168 hours after trial product administration Measured 10 days after dosing
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇬🇧Cambridge, United Kingdom