Dose Study in Growth Hormone Deficient Adults Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083
Dose Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC126-0083 in Growth Hormone Deficient Adults (GHDA)
2 other identifiers
interventional
33
1 country
3
Brief Summary
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of NNC126-0083 in growth hormone deficient adults
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2008
Shorter than P25 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 14, 2008
CompletedFirst Posted
Study publicly available on registry
July 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedFebruary 8, 2017
February 1, 2017
8 months
July 14, 2008
February 6, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and tolerability (adverse events, local tolerability, physical examination)
0 to 10 days after third dosing, (day 15-25 after first dose)
Secondary Outcomes (1)
Cmax, maximum concentration of IGF-I
after trial product administration
Study Arms (4)
A
EXPERIMENTALB
EXPERIMENTALC
EXPERIMENTALD
EXPERIMENTALInterventions
Dose level 1; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
Eligibility Criteria
You may qualify if:
- GHDA subjects as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II
- GH replacement therapy for more than 3 months
- Body Mass Index (BMI, kg/m2) of 22.0 to 35.0 kg/m2, both inclusive
You may not qualify if:
- Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
- Malignant disease
- Proliferative retinopathy judged by retina-photo within the last year - only with concomitant diabetes
- Heart insufficiency, NYHA class greater than 2
- Subjects with diabetes with an HbA1C above 8.0%
- Diabetic receiving insulin treatment
- Stable pituitary replacement therapy for less than 3 months
- Impaired liver function
- Impaired kidney function
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (3)
Novo Nordisk Investigational Site
Århus C, 8000, Denmark
Novo Nordisk Investigational Site
København Ø, 2100, Denmark
Novo Nordisk Investigational Site
Odense, 5000, Denmark
Related Publications (1)
Sondergaard E, Klose M, Hansen M, Hansen BS, Andersen M, Feldt-Rasmussen U, Laursen T, Rasmussen MH, Christiansen JS. Pegylated long-acting human growth hormone possesses a promising once-weekly treatment profile, and multiple dosing is well tolerated in adult patients with growth hormone deficiency. J Clin Endocrinol Metab. 2011 Mar;96(3):681-8. doi: 10.1210/jc.2010-1931. Epub 2010 Dec 22.
PMID: 21177789RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2008
First Posted
July 15, 2008
Study Start
July 1, 2008
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
February 8, 2017
Record last verified: 2017-02