Norditropin SimpleXx (growth hormone)
Drug3mg/subject/day over two consecutive days
Other names: Norditropin® SimpleXx®
NCT Number: NCT01090778
This is an exploratory trial with four cross-over arms measuring the pharmacokinetic and pharmacodynamic profiles of growth hormone using two different modes of growth hormone administration (subcutaneous infusion into the abdomen or subcutaneous bolus injection in the thigh) in 8 adult male or female patients with growth hormone deficiency during interval exercise or in supine rest. The order of dosing regimen within the groups and between the groups will be randomised. All patients will go through four different treatment sessions:A/B Single subcutaneous bolus injection, supine rest without/with interval exercise, sessions C/D: Continuous subcutaneous infusion, supine rest without/with interval exercise. Hypotheses: 1) There is day-to-day variation of exogenous growth hormone, 2)Concentration of growth hormone decreases due to exercise compared to supine rest, 3)There is a circadian variation in pharmacokinetics of exogenous growth hormone infused subcutaneously
Looking for future studies?
Notify Me18 year–75 year
All sexes
Interventional
Phase 2
Medical Department M, Aarhus University Hospital, Aarhus C, Central Jutland, Denmark
The subjects will attend a screening visit and four treatment sessions. The dosing visits will comprise either 2-day hospital stay for the bolus injection group or 3 day hospital stay for the infusion group.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
3mg/subject/day over two consecutive days
Other names: Norditropin® SimpleXx®
Time frame: 48 hours
Pharmacokinetic profiles of growth hormone administrated subcutaneously (3 mg/day) as a bolus in the adult patients with growth hormone deficiency during interval exercise or in supine rest.
Time frame: 60 hours
To compare pharmacokinetic profiles of growth hormone administrated subcutaneously (3 mg/day) as an infusion in the adult patients with growth hormone deficiency during interval exercise or in supine rest.
Aarhus University Hospital
Other
Pharmacokinetic Profiles of GH Using Two Different Administration Regimes; a Bolus and an Infusion Both With and Without Exercise, in Adults With Growth Hormone Deficiency
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04615273
Bone Diseases, Bone Diseases, Developmental
Birmingham, Alabama, United States
View Trial DetailsNCT04614337
Bone Diseases, Bone Diseases, Developmental
Sacramento, California, United States
View Trial DetailsNCT05250063
Bone Diseases, Bone Diseases, Developmental
San Diego, California, United States
View Trial DetailsNCT03422081
Bone Diseases, Bone Diseases, Developmental
Lille, France
View Trial Details