EUCTR2015-001625-16-GB进行中（未招募）1 期
A Phase 2, Single-Arm, Open-Label Study to Evaluate the Safety and Tolerability of PBI-4050 and of its Effects on the Inflammatory, Fibrosis,Diabetes and Obesity Biomarkers in Subjects with Alström Syndrome - Phase II Study of PBI-4050 in Subjects with Alström Syndrome
ProMetic BioSciences Inc.0 个研究点目标入组 18 人开始时间: 2015年9月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 18
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
入选标准
- •1.Subject is 16 years of age or older at screening.
- •2.Subject has signed informed consent.
- •3.Subject has a documented diagnosis of Alström syndrome, confirmed by genetic testing before screening.
- •4.Subject on diabetes treatment has been receiving the same antidiabetic agent(s) for a minimum of 1 month before screening.
- •5.Subject is able and willing to self-monitor blood glucose level at home or can obtain adequate assistance from care givers.
- •6.Female subjects of childbearing potential who are sexually active with a nonsterile male partner must have a negative serum or urine pregnancy test at screening and agree to use adequate birth control from screening throughout the study and for 30 days after the last IMP administration.
- •If a male subject has not been vasectomized at least 6 months before screening and partners with a woman of childbearing potential, he must be willing to use an acceptable contraceptive method throughout the study and for 30 days after the last IMP administration.
- •Explanatory note: A female subject is considered to be of childbearing potential unless she has had a hysterectomy, is at least one year post-menopausal, or has undergone tubal ligation. Adequate birth control includes at least one medically approved and highly effective method of birth control, defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, such as implants, injectables, oral contraceptives combined with at least one barrier method.
- •Acceptable contraceptive methods for a male subject include simultaneous use of condoms and, for his female partner, the use of hormonal contraceptives, intra-uterine contraceptive device, or diaphragm with intravaginally applied spermicide. Only male subjects whose vasectomy has been confirmed by semen analysis at least 3 months after the vasectomy are allowed not to use acceptable contraceptive methods.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 17
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Subject has recent or on-going infection requiring systemic treatment with an anti-infective agent within 30 days before screening.
- •2.Subject has had at least two documented episodes of severe hypoglycaemia within 12 months before screening. Severe hypoglycaemia is defined as an episode of confirmed hypoglycaemia (glucose < 3.0 mmol/L) that required parenteral treatment with intramuscular injection of glucagon or intravenous injection of dextrose, an episode of confirmed hypoglycaemia that did not require parenteral treatment but involved severe neuroglycopenic symptoms, or an episode of unconfirmed hypoglycaemia that resulted in seizure or coma.
- •3.Subject has uncontrolled hypertension with BP > 170/100 mmHg as determined at screening.
- •4.Subject has alanine transaminase (ALT) or aspartate transaminase (AST) level = 5 × upper limit of normal (ULN) at screening.
- •5.Subject is currently using weight loss medications at screening. Subjects may be re-screened after stopping the weight loss medication for a period of at least 5 half-lives.
- •6.Subject has used any moderate/potent inducer or inhibitor of CYP2C9 isozyme or any strong inducer or inhibitor of cytochrome P450 (CYP) 3A isozyme within 30 days prior to the first study drug administration.
- •7.Subject has a history of chronic alcohol or other substance abuse as determined at screening.
- •8.Woman who is pregnant, breast-feeding, or planning a pregnancy during the course of the study as determined at screening.
- •9.Subject has any condition that, in the investigator’s opinion, is likely to interfere with study conduct and compliance.
- •10.Subject has a history of an allergic reaction to PBI-4050 or any of its excipients.
研究者
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