A Single-Dose, Open-Label, Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Oral Fampridine-PR 10 mg in Chinese, Japanese, and Caucasian Adult Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Percentage of participants with treatment-emergent adverse events in each ethnic group
研究概览
简要总结
The primary objective of the study is to determine the Pharmacokinetic (PK) and safety profiles of fampridine-PR 10 mg in Chinese and Japanese adult healthy volunteers. The secondary objective of this study is to compare the PK and safety profiles of fampridine-PR 10 mg among the Chinese, Japanese, and Caucasian adult healthy volunteers.
详细描述
The Caucasian group is included to allow comparison of pharmacokinetic and safety data from different race groups to be performed with data obtained from the same study under the same controlled conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
- •Subjects of Chinese or Japanese origin (at least both maternal and paternal grandparents of Chinese or Japanese origin, respectively), or Caucasian subjects. Japanese subjects should be on Japanese diet on a regular basis.
- •All male subjects and female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 4 weeks after their single dose of study treatment.
- •Body Mass Index (BMI) within the range 18.5 to 30 kg/m2 (inclusive).
- •Normal urinalysis results as determined by the Investigator for the following parameters: protein, glucose, specific gravity, ketones, urobilinogen, bilirubin, pH, and blood.
- •Normal 12-lead ECG as determined by the Investigator.
排除标准
- •Known history of human immunodeficiency virus (HIV) infection or positive test result for HIV antibodies.
- •Known history of hepatitis B or hepatitis C infection, hepatitis B carrier (positive test result for Hepatitis B Surface Antigen [HBsAg]), or hepatitis C infection (positive test result for Hepatitis C virus antibody [HCV Ab]).
- •Psychiatric or neurological disorders.
- •History of epilepsy or other convulsive disorders.
- •Any cardiovascular, renal, gastrointestinal, respiratory, metabolic disorder, or other major disease, as determined by the Investigator.
- •Clinically significant abnormal hematology or blood chemistry values at Screening, as determined by the Investigator; or any screening values for alanine aminotransferase (ALT) and aspartate aminotransferase (AST) that are 1.5 times greater than the upper limit of the normal; any clinically significant (as determined by the Investigator) elevated screening values for bilirubin or creatinine; creatinine clearance lower than 80 mL/minute; any low screening values for platelets or hemoglobin; or an out of normal range for white blood cells (WBC).
- •History of alcohol abuse (as defined by the Investigator) within the previous 2 years, or a blood screen positive for alcohol.
- •History of drug abuse (as defined by the Investigator) within the previous 2 years, or a urine screen positive for cannabinoids, barbiturates, amphetamines, and benzodiazepines.
- •Premalignant and malignant disease.
- •History of clinically significant severe allergic or anaphylactic reactions.
- •Known allergy to pyridine-containing substances.
- •Active bacterial or viral infection within the previous month.
- •Female subjects who are pregnant or currently breastfeeding.
- •Previous participation in another investigational drug study within the last 3 months.
- •Treatment with any prescription medication within the 28 days prior to Day -
- •(Treatment with pharmaceutical-grade vitamins is allowed provided the dose and regimen have been stable for the 28 days prior to Day -1.)
- •Treatment with any over-the-counter products, including herbal-containing and/or caffeine-containing preparations, and/or alternative health preparations and procedures within the 2 days prior to Day -
- •Donation of blood (500 mL or greater) within 56 days prior to study dosing or plasma donation within 7 days prior to study dosing.
- •Inability to comply with study requirements.
- •Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, make the subject unsuitable for enrollment.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Chinese Subpopulation: Fampridine-PR 10 mg
Chinese ethnic participants were administered a single dose of Fampridine-PR 10 mgs
干预措施: BIIB041 (Fampridine-PR) (Drug)
Japanese Subpopulation: Fampridine-PR 10mg
Japanese ethnic participants were administered a single dose of Fampridine-PR 10 mgs
干预措施: BIIB041 (Fampridine-PR) (Drug)
Caucasian Subpopulation: Fampridine-PR 10mg
Caucasian ethnic participants were administered a single dose of Fampridine-PR 10 mgs
干预措施: BIIB041 (Fampridine-PR) (Drug)
结局指标
主要结局
Percentage of participants with treatment-emergent adverse events in each ethnic group
时间窗: Day 1 to Day 7
Observed maximum (peak) plasma 4-aminopyridine (4-AP) concentration (Cmax)
时间窗: Day 1 (0 to 24 Hours After Dosing)
Time to reach Cmax following study treatment administration (Tmax)
时间窗: Day 1 (0 to 24 Hours After Dosing)
Area under the time-concentration curve from time zero to infinity (AUC0-∞)
时间窗: Day 1 (0 to 24 Hours After Dosing)
Apparent elimination half-life (T1/2)
时间窗: Day 1 (0 to 24 Hours After Dosing)
Renal clearance of the drug from plasma
时间窗: Day 1 (0 to 24 Hours After Dosing)
Renal clearance as a fraction of total clearance
时间窗: Day 1 (0 to 24 Hours After Dosing)
Cumulative excreted drug amount at specified sampling intervals (calculated using the concentration data)
时间窗: Day 1 (0 to 24 Hours After Dosing)
次要结局
未报告次要终点