NCT02436447已完成1 期
A Phase 1, 7 Day Repeat Dose, Parallel-Group, Open-Label Study to Evaluate the Safety and Pharmacokinetics of Intravenous Infusion of MTP-131 Administered in Subjects With Impaired Renal Function
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 主要终点
- Mean peak plasma concentration (Cmax) of MTP-131 (ng/ml) in each cohort
研究概览
简要总结
This study is a Phase 1, open-label, parallel group, multiple dose study, in subjects over 18 years, to evaluate the safety, tolerability, and pharmacokinetics of one-hour intravenous infusion of MTP-131 administered for 7 consecutive days. Twenty-four subjects are planned to be enrolled into 4 cohorts of varying renal function, with each cohort consisting of 6 subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is ≥18 years-of-age at the Screening Visit.
- •Subject has signed an ICF before any study specific procedures are performed.
- •Subjects selected for each cohort must satisfy the following creatinine clearance (CLCR) criteria (as determined by 24 hour urine collection and analysis):
- •Cohort 1 - Normal Renal Function, 24 hour CLCR ≥ 90 mL/min
- •Cohort 2 - Mild renal impairment, 24 hour CLCR ≥ 60-89 mL/min
- •Cohort 3 - Moderate renal impairment, 24 hour CLCR ≥ 30-59 mL/min
- •Cohort 4 - Severe renal impairment, 24 hour CLCR <30 not requiring dialysis
- •Have a history of stable renal impairment as determined by standard estimated creatinine clearance methodology (at least 1 month within the same descriptive cohort) and be in a stable physical condition based on findings of medical history.
- •Women of childbearing potential must agree to use 1 of the following methods of birth control from the date they sign the ICF until two months after the last dose of study drug:
- •Abstinence, when it is in line with the preferred and usual lifestyle of the subject. Subject agrees to use an acceptable method of contraception should they become sexually active.
- •Maintenance of a monogamous relationship with a male partner who has been surgically sterilized by vasectomy (the vasectomy procedure must have been conducted at least 60 days prior to the Screening Visit or confirmed via sperm analysis).
- •Barrier method (e.g., condom or occlusive cap) with spermicidal foam/gel/film/cream AND either hormonal contraception (oral, implanted, or injectable) or an intrauterine device or system.
排除标准
- •Subject has history of any concurrent medical condition which, in the opinion of the investigator, significantly increases the potential risks associated with administration of MTP-131 or any other aspect of study participation, with the exception of renal impairment.
- •Female subjects who are pregnant, planning to become pregnant, or lactating.
- •Subject has history of cancer (with the exception of non-melanoma skin cancer), unless the subject has documentation of completed curative treatment
- •Subject has history of renal transplantation.
- •Subject has active inflammatory renal disease.
- •Subject has a history of histamine intolerance (e.g., a known deficiency of endogenous or exogenous histamine degradation).
- •Subject is currently receiving treatment with chemotherapeutic agents or immunosuppressant agents.
- •Subject has positive serology for HIV 1, HIV 2, HBsAg or HCV.
- •Subject has donated or received blood or blood products within the past 30 days.
- •Subject participated in a clinical study involving investigational product within 30 days prior to the planned date of study drug administration.
- •Subject has a history of clinically significant hypersensitivity or allergy to any of the excipients contained in the study drug.
- •Subject has a history of active alcoholism or drug addiction during the year before the Screening Visit.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Normal renal function
Experimental
干预措施: MTP-131 (Drug)
Mild renal impairment
Experimental
干预措施: MTP-131 (Drug)
Moderate renal impairment
Experimental
干预措施: MTP-131 (Drug)
Severe renal impairment
Experimental
干预措施: MTP-131 (Drug)
结局指标
主要结局
Mean peak plasma concentration (Cmax) of MTP-131 (ng/ml) in each cohort
时间窗: Assessed up to Day 14
次要结局
- Incidence of Adverse Events(Assessed up to Day 14)
研究者
相似试验
已完成
1 期
Study to Evaluate Drug-drug Interaction, Safety and Tolerability in Case of the Co-administration of D565 and D930GlaucomaNCT05207761Chong Kun Dang Pharmaceutical32
已完成
1 期
Renal PK Study of LC350189GoutHyperuricemiaNCT04066712LG Chem37
已完成
1 期
Single Dose Manufacturing Site (Pfizer vs. BIP) And Device (Prefilled Syringe vs. Prefilled Pen) Comparability Study For Bococizumab In Healthy VolunteersHealthyNCT02458209Pfizer470
已完成
1 期
Study to Evaluate the Pharmacokinetics and Safety of GSK2336805 in Subjects With Hepatic Impairment and Healthy Matched Control SubjectsHepatitis CNCT01827657GlaxoSmithKline31
已完成
1 期
A Drug-Drug Interaction Study of CTL0901 and CTL0902 Compared to Coadministration in Healthy Adult VolunteersHealth, SubjectiveNCT05009368Celltrion41