EUCTR2008-000500-83-BE进行中（未招募）不适用
A phase II exploratory, ascending dose, multicentre study to investigate the pharmacodynamics, pharmacokinetics, safety and tolerability, of BIM23A760 in acromegalic patients.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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.
- •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
排除标准
- •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
- •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
- •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.
研究者
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