NCT01316055已完成1 期
A Parallel, Three Arm, Open-label, Multi-dose Pharmacokinetic Study of Dalfampridine-ER 7.5 mg Twice Daily in Both Healthy Volunteers and Those With Mild and Moderate Renal Impairment
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
- 42
- 试验地点
- 2
- 主要终点
- The Steady State Area Under the Drug Concentration Time Curve From 0 to 12 Hours Post Dose AUC(0-12).
研究概览
简要总结
The steady-state pharmacokinetics of Dalfampridine-ER (extended release) 7.5 mg (milligram) tablets in healthy adult volunteers and those with mild and moderate renal impairment, and examine between group comparisons.
详细描述
Pharmacokinetics in normal, mildly renally impaired, and moderately renally impaired 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Either gender between the ages of 18 and 75 years
- •Have a body mass index (BMI) ranging between 18.5 - 35.0 kg/m2, inclusive
- •Have adequate cognitive function to understand and sign the IRB approved informed consent prior to the performance of any study-specific procedures
- •Be willing and able to comply with all trial requirements
- •Fit into one of three 12-subject groups: normal renal function (CrCl > 80 mL/min), mild renal impairment (CrCl 51-80 mL/min), and moderate renal impairment (CrCl 30-50 mL/min)
- •Have sufficient venous access to permit blood sample collection
- •Women of childbearing potential must have a negative β-HCG pregnancy test at the Screening Visit.
排除标准
- •Women who are either pregnant or breastfeeding, and women of childbearing potential (i.e., has not had a hysterectomy or bilateral oophorectomy, or is not at least two years postmenopausal) who are engaged in active heterosexual relations and not using any of the following birth control methods: tubal ligation, implantable contraception device, oral, patch or injectible contraceptive, double barrier method, or sexual activity restricted to a vasectomized partner;
- •History of seizure(s);
- •Unstable, acute, or severe (CrCl < 30 mL/min) renal failure;
- •Clinically significant abnormal findings on the physical examination, ECG, vital signs, medical history, or clinical laboratory results during screening (other than abnormal renal values);
- •Any unstable cardiovascular, enterohepatic, respiratory, or immunologic disorder or disease that may substantially affect the pharmacokinetics of Dalfampridine-ER;
- •Known allergy to pyridine-containing substances, or any of the inactive ingredients of the Dalfampridine-ER tablet (colloidal silicon dioxide, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide);
- •Participation in an investigational drug trial 30 days prior to Screening or plans to enroll in an investigational drug trial at any time during this study;
- •Any medical condition including psychiatric disease that would interfere with the interpretation of the study results or the conduct of the study;
- •Subject has started a new medication (prescription, vitamins, herbal medications, or other over-the-counter medications), or had a change in their existing medication within 30 days prior to screening;
- •History of drug or alcohol abuse in the past 2 years, or tests positive for drugs of abuse at Screening;
- •Donation of blood or blood components within 30 days prior to administration of investigational drug. The Investigator should instruct subjects who participate in this study not to donate blood or blood components during their participation in the study and up to four weeks after the completion of the study.
研究组 & 干预措施
Healthy: Dalfampridine-ER 7.5 mg
Active Comparator
Dalfampridine-ER 7.5 mg single and steady-state dosing in healthy volunteers
干预措施: Dalfampridine-ER (Drug)
Mild renal: Dalfampridine-ER 7.5 mg
Active Comparator
Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with mild renal impairment
干预措施: Dalfampridine-ER (Drug)
Moderate renal: Dalfampridine-ER 7.5 mg
Active Comparator
Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with moderate renal impairment
干预措施: Dalfampridine-ER (Drug)
结局指标
主要结局
The Steady State Area Under the Drug Concentration Time Curve From 0 to 12 Hours Post Dose AUC(0-12).
时间窗: 0 and 1,2,3,4,5,6,8, and 12 hours after the last dose
AUC(0-12) was based on blood samples taken at specified outcome measure time frame for dalfampridine-ER 7.5 mg tablets in healthy adult volunteers and people with mild or moderate renal impairment.
次要结局
- The Maximum Measured Plasma Concentration (Cmax) at Steady State, of Dalfampridine-ER 7.5 mg Tablets in Healthy Adult Volunteers and Those With Mild and Moderate Renal Impairment and Examine Between-group Differences.(7 days)
- The Steady State Fractional Clearance, Calculated as the Dose / AUC(0-12) (CL/Fss) of Dalfampridine-ER 7.5 mg Tablets in Healthy Adult Volunteers and Those With Mild and Moderate Renal Impairment and Examine Between-group Differences.(7 days)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
A Study to Evaluate the Pharmacokinetic and Pharmacodynamic Interactions Between HGP0904, HGP0608, and HCP1306 in Healthy Male Subjects.HealthyNCT04081844Hanmi Pharmaceutical Company Limited31
已完成
1 期
Pharmacokinetics and Pharmacodynamics Study of Gemcabene in Healthy VolunteersHypercholesterolemiaNCT02587364NeuroBo Pharmaceuticals Inc.50
已完成
1 期
To Evaluate the PK, PD, Safety and Drug Tolerance of JW0302 in Healthy VolunteersHealthyNCT05784155JW Pharmaceutical44
已完成
1 期
To Evaluate the PK, PD, Safety and Drug Tolerance in Healthy VolunteersHealthyNCT05433844JW Pharmaceutical44
已完成
1 期
CKD-397 Drug-drug Interaction Study (B)Healty Male VolunteersNCT02247505Chong Kun Dang Pharmaceutical29