A randomised, double blind, placebo-controlled, multiple dose, dose-escalating, sequential dose group trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) in Growth Hormone deficient adults (AGHD)

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2008-001061-29-DK
• Date of registration: 29/04/2008
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public title: A randomised, double blind, placebo-controlled, multiple dose, dose-escalating, sequential dose group trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) in Growth Hormone deficient adults (AGHD)
• Scientific title: A randomised, double blind, placebo-controlled, multiple dose, dose-escalating, sequential dose group trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) in Growth Hormone deficient adults (AGHD)
• Date of first enrolment: 17/06/2008
• Target sample size: 32
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-001061-29
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: yes Other trial design description: multi dose If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Denmark

Key inclusion & exclusion criteria

Inclusion criteria:
1. Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
2. AGHD male or female subjects as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II1
3. On GH replacement therapy > 3 months
4. Body Mass Index (BMI, kg/m^2) of 18.5 to 35.0 kg/m^2, both inclusive
5. Age =20 and = 65 years

All subjects will be required to discontinue GH replacement treatment 2 weeks before first NNC126-0083 administration.

Fertile AGHD females must agree to use appropriate contraceptive methods and have a negative pregnancy test at inclusion. (The Danish Medicines Agency usually finds that contraceptive pills, intrauterine devices, injection of prolonged gestagen, subdermal implantation, hormonal vaginal devices and transdermal patches are safe contraceptive methods in connection with medicinal product trials). Fertile femals included in the trial must thus use one of the above-mentioned contraceptive methods together with a barrier method during the entire treatment period and for a period of at least 5 weeks after last visit.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Participation in any other clinical trial involving any investigational products within the last three months prior to this trial
2. Previous participation in this trial (randomised)
3. Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (e.g. barrier method plus contraceptive pills, intrauterine devices, injection of prolonged gestagen, subdermal implantation, hormonal vaginal devices or transdermal patches) for the duration of the study
4. Malignant disease
5. Hypophysectomy due to gigantism
6. Proliferative retinopathy judged by retina-photo within the last year – only with concomitant diabetes
7. Heart insufficiency, NYHA class >2
8. HbA1_C>8.0% - Poorly controlled patients with diabetes mellitus
9.Insulin-treated diabetes mellitus subjects
10. Stable pituitary replacement therapy for less than 3 months
11. Impaired liver function, defined as alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) = 3 times upper normal range
12. Impaired renal function, defines as s-creatinnine =135 µmol/L (=1.5 mg/dL) for males and = 110 µmol/L (=1.3 mg/dL) for females
13. Known or suspected allergy to the trial product or related products
14. History of any illnesses or disease that, in the opinion of the Investigator might confound the results of the trial or pose additional risk in administering the trial product to the subject
15. Clinically significant illness within 4 weeks of dosing
16. Any clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator
17. Active hepatitis B, measured by surface antigen B (HbsAg) and/or active hepatitis C, measured by positive hepatitis C virus antibody test
18. Positive result of test for human immunodeficiency virus (HIV) antibodies
19. Clinically significant abnormal ECG at screening as evaluated by Investigator
20. Use of any non-prescribed systemic or topical medication except routine vitamins, within 2 weeks prior to dosing. Occasional use of acetylsalicylic acid and paracetamol is permitted
21. Donation of blood or plasma in the past month or in excess of 500 ml within the 12 weeks preceding screening
22. Surgery or trauma with significant blood loss within the last 3 months prior to dosing.
23. A significant history of alcoholism or drug/chemical abuse, or who consumes more than 28 units of alcohol per week (one unit of alcohol equals about 250 ml of beer or lager, 1 glass of wine, or 20 ml of spirits)
24. Mental incapacity or language barriers which preclude adequate understanding or cooperation, who are unwilling to participate in the trial or who in the opinion of their general practitioner or the Investigator should not participate in the trial
25. Strenuous exercise during the trial
26. Any condition interfering with trial participation or evaluation or that may be hazardous to the subject




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Growth hormone deficiency
MedDRA version: 9.1 Level: LLT Classification code 10056438 Term: Growth hormone deficiency

Intervention(s)

Product Name: NN8630
Product Code: NNC 126-0083
Pharmaceutical Form: Solution for injection
Current Sponsor code: NNC 126-0083
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6,8-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Secondary Objective: To determine pharmacokinetics (PK) and pharmacodynamics (PD) of ascending multiple sc doses of NNC126-0083 in AGHD male and female subjects.

Primary end point(s): Safety and Tolerability Parameters after four doses of NNC126-0083: Physical examination, body weight, vital signs and ECG, clinical laboratory tests (haematology, biochemistry, urinalysis, fasting glucose, fasting insulin), NNC126-0083 antibodies, Adverse Events (AE’s) including injection site reactions.

Main Objective: To determine safety and tolerability of ascending multiple subcutaneous (sc) doses of NNC126-0083 in AGHD male and female subjects compared to placebo.

Secondary ID(s)

NN8630-1823