E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000599 |
E.1.2 | Term | Acromegaly |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate the pharmacodynamics (PD) of BIM 23A760, administered by single subcutaneous (s.c.) injection to acromegalic patients. |
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E.2.2 | Secondary objectives of the trial |
To investigate the pharmacokinetics (PK), safety and tolerability of BIM 23A760, administered by single s.c. injection to acromegalic patients. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All patients must fulfil the following: 1) The patient has provided written informed consent prior to any study related procedures. 2) The patient age is between 18 and 75 years inclusive. 3) The patient is male, or a woman who has been post menopausal for at least 3 years. In addition women with a documented infertility (natural or acquired) may be included. 4) The patient must agree that, if their partner is at risk of becoming pregnant, they will use an effective method of contraception as defined in the ICH M3 guideline, and this should be continued for two months after the IMP administration. 5) The patient must have documentation supporting the diagnosis of acromegaly, including elevated GH and/or IGF-I levels. 6) The patient has a mean serum GH concentration >3.5µg/L during a 5h profile and an IGF-I serum level above normal during the screening period. |
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E.4 | Principal exclusion criteria |
Patients will not be included in the study if: 1) The patient has undergone pituitary surgery within 3 months prior to study entry or within 6 weeks in case of macro adenoma. 2) The patient has undergone radiotherapy anytime prior to study entry. 3) It is anticipated that the patient will receive pituitary surgery or radiotherapy during the study. 4) The patient has received long acting somatostatin analogues within 6 months prior to study entry. 5) The patient has received dopamine agonist or short acting octreotide within 1 month before entering the study. 6) The patient has received GH antagonist at anytime prior to study entry 7) The patient is known for not being controlled by somatostatin analogues at anytime prior to study entry. 8) The patient has any known uncontrolled cardiovascular disease and/or concomitant medication(s) associated with risk of severe hypotension. 9) The patient has any known valvular disease. 10) The patient has any known uncontrolled metabolic disease. 11) The patient has insulin-treated diabetes or HbA1c > 7.5%. 12) The patient has clinically significant hepatic abnormalities and/or AST and/or ALT>3 ULN during the screening period. 13) The patient has any severe renal or hepatic insufficiency. 14) The patient is receiving any Hormone Replacement Therapy (HRT). 15) The patient is receiving neuroleptic antipsychotic/antiemetic drugs. 16) The patient has abnormal findings during the screening period, any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardise the patient’s safety. 17) The patient has been treated with any other IMP prior to the first study visit without undergoing a wash-out period of 7 times the elimination half-life of the investigational compound. 18) The patient has a known hypersensitivity to any of the test materials or related compounds. 19) The patient is likely to require treatment during the study with drugs that are not permitted by the study protocol. 20) The patient has a history of, or known current, problems with alcohol or drug abuse. 21) The patient has any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude. |
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E.5 End points |
E.5.1 | Primary end point(s) |
PD response: Maximum observed % inhibition of GH. |
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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 | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | No |
E.8.1.1 | Randomised | No |
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 | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
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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The study will be considered to have finished at the end of study visit of the last patient in the last cohort. |
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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 | |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 8 |