Acromegaly MedDRA version: 9.1 Level: LLT Classification code 10000599 Term: Acromegaly
Conditions
Interventions
Product Code: BIM23A760
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Not available
CAS Number: 868562-36-1
Current Sponsor code: BIM23A760
Other descriptive name: Dopast
Sponsors
Ipsen Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
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 Investigational Medicinal Product (IMP) administration. 5. The patient must have documentation supporting the diagnosis of acromegaly, including elevated GH and/or insulin-like growth factor - I (IGF-I) levels. 6. The patient has a mean serum GH concentration > 3.5 µg/l during a 5h profile and an IGF-I serum level above normal during the screening period. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 macroadenoma. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the pharmacodynamics (PD) of BIM 23A760, administered by single subcutaneous (s.c.) injection to acromegalic patients.;Secondary Objective: To investigate the pharmacokinetics (PK), safety and tolerability of BIM 23A760, administered by single s.c. injection to acromegalic patients.;Primary end point(s): PD response: Maximum observed % inhibition of GH. | — |
Countries
Belgium, Italy, Latvia, Lithuania
Outcome results
None listed