EUCTR2015-003868-37-BE进行中（未招募）1 期
A phase IIa, open-label, single-arm, two stage, multi-centre study to investigate the pharmacodynamics, pharmacokinetics, safety and tolerability of repeated subcutaneous administration of BIM23B065 in subjects with acromegaly
试验速览
- 阶段
- 1 期
- 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
- •(1) Provided written informed consent prior to any study related procedures.
- •(2) Subjects will have a documented diagnosis of acromegaly.
- •(3) Subjects will have active acromegaly confirmed by a mean serum concentration of GH over 2 hours > 2.5 µg/L at screening analysed by central laboratory.
- •(4) Subjects who have had pituitary surgery must be >8 weeks post-surgery.
- •(5) 18 to 75 years of age.
- •(6) Negative pregnancy test (female subjects).
- •(7) Female who is either of non-childbearing potential or who is not pregnant at screening and agrees to use highly effective contraception during whole duration of the study. Non-childbearing potential is defined as being postmenopausal for at least 1 year, or women with documented infertility (natural or acquired).
- •(8) Male subjects must agree that, if their partner is at risk of becoming pregnant, they will use a medically accepted, effective method of contraception (i.e. condom) for the duration of the treatment period of the study.
- •(9) Subjects must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period and willing to return to the clinic for the follow up evaluation as specified in the protocol.
- •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 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •(1) The subject has received long-acting SSA within 12 weeks prior screening (e.g.octreotide long acting release (LAR), lanreotide Autogel, pasireotide LAR).
- •(2) The subject has received short-acting SSA within 1 week (e.g. octreotide SC) prior to screening.
- •(3) The subject has received a dopamine agonist within 6 weeks (e.g., bromocriptine or cabergoline) prior to screening.
- •(4) The subject has received GH antagonist within 12 weeks prior to screening (e.g., pegvisomant).
- •(5) The subject had undergone radiotherapy to the pituitary gland at any time prior to study entry.
- •(6) It is anticipated that the subject will undergo pituitary surgery or radiation to the pituitary gland during the study, or will require additional medical therapy for acromegaly (including SSA, pegvisomant, or dopamine agonists) during the study.
- •(7) If the subject has any history of postural hypotension or evidence of postural hypotension at screening (>= 20 mm Hg decrease in SBP, >= 10 mm Hg decrease in diastolic blood pressure, or >=30 bpm increases in pulse rate, after standing for 2 minutes from resting supine position of at least 10 min).
- •(8) Subject with poorly controlled diabetes mellitus (presence of ketoacidosis or a glycosylated hemoglobin level >10%).
- •(9) Subject with diabetes treated with insulin for less than 6 weeks prior to study entry, or with an unstable insulin dose in the 6 weeks prior to study entry or HbA1c>10%.
- •(10) Subject is taking beta-blockers (which can inhibit compensatory increases in HR during hypotensive episodes).
- •(11) Subject is taking Clonidine, Alpha-blockers, Verapamil and diltiazem, Amiodarone, Ivabradine and Anti-cholinesterase drugs.
- •(12) Subject is being treated for hypertension and in the opinion of the investigator their antihypertensive medication puts them at increased risk of postural hypotension.
- •(13) Subject is hypotensive at screening as defined as systolic < 90 mmHg and/or diastolic <60 mmHg.
- •(14) Subject has clinically significant hepatic abnormalities and/or alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) =2 x ULN and/or alkaline phosphatase (AP) =2 x ULN and/or total bilirubin =1.5 x ULN and gamma-glutamyl transferase (GGT) =2.5 x ULN during the Screening period (local laboratory results).
- •(15) Subject has a compression of the optic chiasm causing visual-field defects.
- •(16) Subject with a life expectancy of < 1 year.
- •(17) Subject is receiving any oestrogen-containing Hormone Replacement Therapy (HRT).
- •(18) Subject is receiving neuroleptic antipsychotic/antiemetic drugs.
- •(19) Subject has clinically significant pancreatic abnormalities and/or amylase and/or lipase =2 x ULN during the Screening period (local laboratory results).
- •(20) Any significant renal abnormalities, including confirmed proteinuria and/or creatinine =1.5x ULN during screening assessed by the local laboratory.
- •(21) Subject has any known uncontrolled cardiovascular disease or any of the following within 6 months of Screening: ventricular or atrial dysrhythmia =CTCAE grade 2, bradycardia = CTCAE grade 2, electrocardiogram (ECG),QTc prolonged = CTCAE grade 2, myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, hypertension not adequately controlled by current medications.
- •(22) Subject with history of, or known current, problems with alcohol or drug abuse.
- •(23) Subject with any mental condition rendering him/her u
研究者
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