A Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency
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) compared to daily dosing of Norditropin® SimpleXx® (somatropin) in children with growth hormone deficiency.
Growth Hormone Disorder
Growth Hormone Deficiency in Children
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomised, Open-labelled, Active-controlled, Multinational, Dose-escalation Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (NNC0195-0092) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency|
- Incidence of adverse events (AEs) [ Time Frame: From first administration of trial product and up until day 35 (final visit) ] [ Designated as safety issue: No ]
- The area under the insulin-like growth factor I (IGF-I) concentration-time curve [ Time Frame: From 0 to 168 hours after dosing ] [ Designated as safety issue: No ]
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||November 2014|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
A single dose administered subcutaneously (s.c., under the skin) of 4 different doses of NNC0195-0092 in an escalating order.
Each subject will be allocated to one dose level only. After completion of each dose cohort, a safety evaluation will be conducted prior to dose escalation.
|Active Comparator: Norditropin®||
Administered subcutaneously (s.c., under the skin) once daily for 7 days. The daily dose is 0.03 mg/kg/day.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01973244
|Contact: Novo Nordiskfirstname.lastname@example.org|
|Wien, Austria, A 1090|
|Brussels, Belgium, 1090|
|Paris, France, 75015|
|Petah Tikva, Israel, 49202|
|Macedonia, The Former Yugoslav Republic of|
|Skopje, Macedonia, The Former Yugoslav Republic of, 1000|
|Bergen, Norway, 5021|
|Ljubljana, Slovenia, 1525|
|Vitoria, Spain, 01009|
|Stockholm, Sweden, 141 86|
|Basel, Switzerland, 4031|
|Study Director:||Global Clinical Registry (GCR, 1452)||Novo Nordisk A/S|