Growth Hormone Disorder | 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
Growth Hormone Disorder research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - Confirmed diagnosis of GHD (growth hormone deficiency) as defined by two different GH (growth hormone) stimulation tests, peak GH level below or equal to 7.0 ng/ml. For children with three or more pituitary hormone deficiencies only one GH stimulation test will be needed. If in accordance with country specific practice, growth hormone deficiency can be defined by only one GH stimulation test, peak GH level below or equal to 7.0 ng/ml. - Pre-pubertal children at screening. Boys: Tanner stage 1 and age above or equal to 6 years and below 13 years. Girls: Tanner stage 1 and age above or equal to 6 years and below 12 years - Body weight above or equal to 16.0 kg and below or equal to 50.0 kg - Stable GH replacement treatment for at least 3 months Exclusion Criteria: - History or presence of malignancy - Overt diabetes mellitus (fasting blood glucose above or equal to 7.0 mmol/l)
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Growth Hormone Disorder
Growth Hormone Deficiency in Children
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:somapacitanA 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.
Drug:somatropinAdministered subcutaneously (s.c., under the skin) once daily for 7 days. The daily dose is 0.03 mg/kg/day.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: December 16, 2013
Completed Date: November 4, 2014
Phase: Phase 1
Primary Outcome: Incidence of adverse events (AEs)
Secondary Outcome: The area under the insulin-like growth factor I (IGF-I) concentration-time curve
Study sponsors, principal investigator, and references
Principal Investigator: Global Clinical Registry (GCR, 1452)
Lead Sponsor: Novo Nordisk A/S