E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Adults with growth hormone disease (AGHD). |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To compare the pharmacokinetic (PK) profiles of 3 mg/subject/day Norditropin® SimpleXx® administrated SC as a bolus in the patients with AGHD during interval exercise or in supine rest. |
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E.2.2 | Secondary objectives of the trial |
1. To compare PK profiles of 3 mg/subject/day GH (Norditropin® SimpleXx®) administrated sc as an infusion in the patients with AGHD during interval exercise or in supine rest. 2. To compare pharmacodynamic (PD) effect of 3 mg/subject/day GH (Norditropin® SimpleXx®) administrated either as a single sc injection or as a sc infusion and combined with or without interval exercise in the patients with AGHD. 3. To compare the response of insulin and glucose in AGHD patients after intake of a standard carbohydrate rich breakfast in the bolus as well as in the infusion group
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Informed consent 2. AGHD male or female subjects as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II 3. Stable GH replacement therapy for at least 3 months 4. Body Mass Index (BMI, kg/m2) from 18,5 to 35.0 kg/m2, both inclusive 5. Achieved final height 6. Age ≥ 18 years
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E.4 | Principal exclusion criteria |
1. AGHD subjects with active malignancy 2. Severe cardiac insufficiency classified according to NYHA III-IV 3. Unstable angina pectoris, acute myocardial infarction (AMI) within the last 12 months 4. Severe, uncontrolled hypertension: sitting blood pressure (BP) > 180/110 mmHg 5. HbA1C > 7,5 % 6. Impaired kidney function: serum creatinine ≥ 150 umol/l according to the hospital lab. 7. Patients on insulin treatment 8. Stable pituitary replacement therapy for less than 3 months 9. Participation in any other clinical trial involving any investigational products within the last three months prior to this trial 10. Any diseases judged by the investigator that could affect the trial 11. Women of fertile age, who are pregnant, planning to become pregnant or breast-feeding. Women of fertile age, who are not currently using adequate contraception methods such as: contraceptive pills, intrauterine device (IUD), hysterectomy or sterilization 12. Known or suspected allergy to the trial product or ingredients of the trial product
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E.5 End points |
E.5.1 | Primary end point(s) |
Pharmacokinetic profiles of the individual hGH plasma concentration curves in treatment sessions with a single sc bolus injection without/with interval exercise
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
The patients will serve as own trial controls |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of the trial is the last visit of the last subject undergoing the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 20 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |