drugset / Trial / NCT00936403
A Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth Hormone
RandomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2009-08
- Primary completion
- 2010-07
- Completion
- 2010-07
Publications
- Results de Schepper J, Rasmussen MH, Gucev Z, Eliakim A, Battelino T. Long-acting pegylated human GH in children with GH deficiency: a single-dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics. Eur J Endocrinol. 2011 Sep;165(3):401-9. doi: 10.1530/EJE-11-0536. Epub 2011 Jul 1.
- Papathanasiou T, Agerso H, Damholt BB, Hojby Rasmussen M, Kildemoes RJ. Population Pharmacokinetics and Pharmacodynamics of Once-Daily Growth Hormone Norditropin(R) in Children and Adults. Clin Pharmacokinet. 2021 Sep;60(9):1217-1226. doi: 10.1007/s40262-021-01011-3. Epub 2021 Apr 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SOMATROPIN PEGOL | Protein / enzyme biologic | 0.01 mg/kg | — |
| Subject | SOMATROPIN PEGOL | Protein / enzyme biologic | 0.02 mg/kg | — |
| Subject | SOMATROPIN PEGOL | Protein / enzyme biologic | 0.04 mg/kg | — |
| Subject | SOMATROPIN PEGOL | Protein / enzyme biologic | 0.06 mg/kg | — |
| Comparator | Somatropin | Protein / enzyme biologic | 0.035 mg/kg | Subcutaneous |
Indications
No indication recorded.