A PHASE II EXPLORATORY, ASCENDING DOSE, MULTICENTRE STUDY TO INVESTIGATE THE PHARMACODYNAMICS, PHARMACOKINETICS, SAFETY AND TOLERABILITY, OF BIM 23A760 IN ACROMEGALIC PATIENTS. - ND

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2008-000500-83-IT
• Date of registration: 26/09/2008
• Prospective Registration: No
• Primary sponsor: BEAUFOUR IPSEN PHARMA
• Public title: A PHASE II EXPLORATORY, ASCENDING DOSE, MULTICENTRE STUDY TO INVESTIGATE THE PHARMACODYNAMICS, PHARMACOKINETICS, SAFETY AND TOLERABILITY, OF BIM 23A760 IN ACROMEGALIC PATIENTS. - ND
• Scientific title: A PHASE II EXPLORATORY, ASCENDING DOSE, MULTICENTRE STUDY TO INVESTIGATE THE PHARMACODYNAMICS, PHARMACOKINETICS, SAFETY AND TOLERABILITY, OF BIM 23A760 IN ACROMEGALIC PATIENTS. - ND
• Date of first enrolment: 29/07/2008
• Target sample size: 24
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-000500-83
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: studio in aperto If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: studio di farmacocinetica e farmacodinamica

Countries of recruitment

Belgium, Italy, Latvia, Lithuania

Key inclusion & exclusion criteria

Inclusion criteria:
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 aged over 60 who has been
post menopausal for at least 5 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 > 4µg/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:
1. The patient has undergone pituitary surgery within 3 months
prior to study entry.
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/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.


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

Health Condition(s) or Problem(s) studied

Acromegaly.
MedDRA version: 9.1 Level: LLT Classification code 10000599 Term: Acromegaly

Intervention(s)

Product Name: BIM23A760
Pharmaceutical Form: Powder for solution for injection
CAS Number: 868562-36-1
Current Sponsor code: BIM23A760
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)

Main Objective: To investigate the pharmacodynamics (PD) of BIM 23A760,
administered by single subcutaneous (s.c.) injection to
acromegalic patients.

Primary end point(s): PD response: Maximum observed % inhibition of GH.

Secondary Objective: To investigate the pharmacokinetics (PK), safety and
tolerability of BIM 23A760, administered by single s.c.
injection to acromegalic patients.

Secondary ID(s)

2008-000500-83-LT

2-55-52060-002