Dose Study in Growth Hormone Deficient Adults Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083

Adult Growth Hormone Deficiency Clinical Trial

Official title:

Dose Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC126-0083 in Growth Hormone Deficient Adults (GHDA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00715689
• Other study ID #: NN8630-1823
• Secondary ID: 2008-001061-29
• Status: Completed
• Phase: Phase 2
• First received: July 14, 2008
• Last updated: February 6, 2017
• Start date: July 2008
• Est. completion date: March 2009

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• GHDA subjects as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II

• Fertile females must agree to use appropriate contraceptive methods and have a negative pregnancy test at inclusion

• GH replacement therapy for more than 3 months

• Body Mass Index (BMI, kg/m2) of 22.0 to 35.0 kg/m2, both inclusive

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Adult Growth Hormone Deficiency
• Dwarfism, Pituitary
• Growth Hormone Disorder

Intervention

Drug:
• NNC126-0083
Dose level 1; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
• NNC126-0083
Dose level 2; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
• NNC126-0083
Dose level 3; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
• NNC126-0083
Dose level 4; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
• placebo
Dose level 1; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
• placebo
Dose level 2; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
• placebo
Dose level 3; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
• placebo
Dose level 4; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks

Locations

Country	Name	City	State
Denmark	Novo Nordisk Investigational Site	Århus C
Denmark	Novo Nordisk Investigational Site	København Ø
Denmark	Novo Nordisk Investigational Site	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Søndergaard 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability (adverse events, local tolerability, physical examination)		0 to 10 days after third dosing, (day 15-25 after first dose)
Secondary	Cmax, maximum concentration of IGF-I		after trial product administration

External Links

•   Clinical Trials at Novo Nordisk