A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency
Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Growth Hormone Disorder; Adult Growth Hormone Deficiency
Intervention: NNC0195-0092 (Drug); Norditropin NordiFlex® (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Novo Nordisk A/S Official(s) and/or principal investigator(s):
Lene Finnerup Nielsen, Study Director, Affiliation: Novo Nordisk A/S
Summary
This trial is conducted in Europe. The aim of the trial is to investigate the safety,
tolerability, availability and distribution in the body of once-weekly long-acting growth
hormone (NNC0195-0092) compared to once daily Norditropin NordiFlex® in adults with growth
hormone deficiency (GHD).
Clinical Details
Official title: A Randomised, Open-labelled, Active-controlled, Multiple Dose, Dose Escalating, Sequential Dose Group Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Once-weekly Long-acting Growth Hormone (NNC0195-0092) Compared to Once-daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Incidence of adverse events (AEs)
Secondary outcome: NNC0195-0092 only: Area under the curve, AUC (0-168h)Norditropin NordiFlex® only: AUC (0-24h) NNC0195-0092, first dose administration only: AUC (0-168h) Norditropin NordiFlex®, first dose administration only: AUC (0-24h) NNC0195-0092: Maximum serum concentration (Cmax) Norditropin NordiFlex®: Cmax Insulin-like growth factor I (IGF-I): AUC (0-168h) IGF-I: Cmax Insulin-like growth factor binding protein-3 (IGFBP-3): AUC IGFBP-3(0-168h) IGFBP-3: Cmax
Eligibility
Minimum age: 20 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Adults with GHD as defined in the consensus guidelines for the diagnosis and
treatment of adults with GHD
- Stable human growth hormone (hGH) replacement therapy for at least 3 months
Exclusion Criteria:
- Participation in another clinical trial within 3 months or receipt of any
investigational medicinal product within 3 months prior to randomisation
- Active malignant disease or malignant disease within the last 5 years with exception
of fully treated local basal cell carcinoma or carcinoma in situ of cervix
- Proliferative retinopathy judged by retina-photo within the last year - only with
concomitant diabetes
- Heart insufficiency, New York Heart Association (NYHA) class above 2
- Adults with GHD with poorly controlled diabetes mellitus with a glycosylated
haemoglobin (HbA1c) 64 mmol/mol (8. 0%) and/or insulin treatment
- Stable pituitary replacement therapy for less than 3 months
Locations and Contacts
København Ø 2100, Denmark
Stockholm 141 86, Sweden
Additional Information
Clinical Trials at Novo Nordisk
Starting date: October 2012
Last updated: November 26, 2013
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