drugset / Trial / NCT01973244
A Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency
RandomizedParallel-groupOpen-labelTreatment
Summary
This trial is conducted in Europe and Asia. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of a single dose of long-acting growth hormone (NNC0195-0092, somapacitan) compared to daily dosing of Norditropin® SimpleXx® (somatropin) in children with growth hormone deficiency.
Timeline
- Start
- 2013-12-16
- Primary completion
- 2014-11-04
- Completion
- 2014-11-04
Publications
- Background Juul Kildemoes R, Hojby Rasmussen M, Agerso H, Overgaard RV. Optimal Monitoring of Weekly IGF-I Levels During Growth Hormone Therapy With Once-Weekly Somapacitan. J Clin Endocrinol Metab. 2021 Jan 23;106(2):567-576. doi: 10.1210/clinem/dgaa775.
- Desrochers J, Backeljauw P, Hojby M, Juul Kildemoes R, Linglart A, Mori J, Leisegang RF. Model-based somapacitan dosing and IGF-I response in children born SGA or with ISS, Noonan or Turner syndromes. J Endocr Soc. 2026 Jun 4;10(7):bvag124. doi: 10.1210/jendso/bvag124. eCollection 2026 Jul.
- 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.
- Juul RV, Rasmussen MH, Agerso H, Overgaard RV. Pharmacokinetics and Pharmacodynamics of Once-Weekly Somapacitan in Children and Adults: Supporting Dosing Rationales with a Model-Based Analysis of Three Phase I Trials. Clin Pharmacokinet. 2019 Jan;58(1):63-75. doi: 10.1007/s40262-018-0662-5.
- Battelino T, Rasmussen MH, De Schepper J, Zuckerman-Levin N, Gucev Z, Savendahl L; NN8640-4042 Study Group. Somapacitan, a once-weekly reversible albumin-binding GH derivative, in children with GH deficiency: A randomized dose-escalation trial. Clin Endocrinol (Oxf). 2017 Oct;87(4):350-358. doi: 10.1111/cen.13409. Epub 2017 Aug 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Somatropin | Protein / enzyme biologic | 0.03 mg/kg | Subcutaneous |
| Subject | somapacitan | Protein / enzyme biologic | 0.02 mg/kg | Subcutaneous |
| Subject | somapacitan | Protein / enzyme biologic | 0.04 mg/kg | Subcutaneous |
| Subject | somapacitan | Protein / enzyme biologic | 0.08 mg/kg | Subcutaneous |
| Subject | somapacitan | Protein / enzyme biologic | 0.16 mg/kg | Subcutaneous |
Indications
No indication recorded.