A Phase 1, Double-Blind, Placebo-Controlled, Randomized Study to Assess the Pharmacokinetics, Safety and Tolerability of Repeat Oral Dosing of ASP1941 and to Explore the Effect of ASP1941 on Glucose Levels in Healthy Adult Subjects (18 to 45 Years and ≥ 65 Years)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Pharmacokinetic profile of ASP1941 (urine): Ae, Ae%, Aelast, Aelast%, Ae24, CLR
研究概览
简要总结
This is a study of the pharmacokinetic profile and safety and tolerability of ASP1941after repeat dosing and the effect of ASP1941 on glucose levels in non elderly and elderly healthy adult male and female subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female, healthy non-elderly (age 18-45 years, inclusive) or healthy elderly (age 65 or over)
- •If female, subject is not pregnant or nursing, and uses medically acceptable contraceptive method to prevent pregnancy from screening until study discharge
- •Body weigh between 60 and 100kg and body Mass Index between 20 and 30kg/m2, inclusive
- •Negative urine screen for drugs of abuse, including alcohol and cotinine
排除标准
- •History of type 1 or type 2 diabetes
- •Fasting plasma glucose level higher than 6.4mmol/L or hemoglobin A1c level higher than 6.2%
- •Presence of renal glucosuria and/or proteinuria
- •Clinically significant history of asthma, eczema, and or any other allergic condition.
- •Clinically significant history of upper gastrointestinal symptoms within the 4 weeks prior to admission to the clinical unit.
- •History of any clinically significant neurological, gastrointestinal, renal, hepatic, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder or disease, or any other medical condition that would preclude participation in the study.
- •History of multiple drug allergies or a known allergy or suspected hypersensitivity to the study drug or any chemically related derivatives of the study drug or any components of the formulation
- •Has hepatitis or a positive result to serology test for hepatitis A antibody Immunoglobulin M, hepatitis B surface antigen or hepatitis C virus at screening
- •Known to be positive for human immunodeficiency virus antibodies.
- •Donated one unit (450 mL) or more of blood or plasma within 60 days prior to the first dose of study medication.
- •Has a history of consuming more than an average of 2 ounces of alcohol-containing products per day or a history of alcoholism or drug/chemical abuse within the last 3 years.
- •Use of any tobacco or nicotine-containing products within 120 days prior to the first dose of study medication.
- •Taken any prescribed systemic or topical medication within 21 days prior to the first dose of study medication with the exception of contraceptives to prevent pregnancy.
- •Taken any systemic or topical over-the counter medication, complementary or alternative medications, e.g., vitamins, herbal, or nutritional supplements, with the exception of acetaminophen, within 10 days prior to the first dose of study medication.
- •Taken an investigational drug within 30 days of the first dose of study medication
研究组 & 干预措施
Arm 1 Non elderly receiving ASP1941
healthy subjects age 18 to 45 years receiving ASP1941
干预措施: ASP1941 (Drug)
Arm 2 Non elderly receiving placebo
healthy subjects age 18 to 45 years receiving placebo
干预措施: Placebo (Drug)
Arm 3 Elderly receiving ASP1941
healthy subjects age ≥ 65 years receiving ASP1941
干预措施: ASP1941 (Drug)
Arm 4 Elderly receiving placebo
healthy subjects age ≥ 65 years receiving placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Pharmacokinetic profile of ASP1941 (urine): Ae, Ae%, Aelast, Aelast%, Ae24, CLR
时间窗: Day 1 at pre-dose and from 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48, 48 to 72, 72 to 96 hours post-dose
Cumulative amount of drug excreted into urine up to the ending time of the last collection period (Ae), Fraction of the drug excreted in urine (Ae) in % up to the ending time of last collection period (Ae%), Cumulative amount of drug or glucose excreted into urine up to the collection time of the last measurable amount (Aelast),Fraction of drug excreted into urine (Ae) in % up to the collection time of the last measurable concentration (Aelast% ), Fraction of glucose excreted into urine up to 24 hrs (Ae24), Renal clearance (CLR)
Number of adverse events (AEs)
时间窗: Through Day 29
Safety as assessed by vital signs, electrocardiogram (ECG), physical examination, and laboratory evaluations
时间窗: Through Day 29
Pharmacokinetic profile of ASP1941 (plasma):AUCtau, CL/F, Cmax, tmax, t1/2, Vz/F, PTR
时间窗: Days 1 and 18 pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose
Area under the curve over the time interval between consecutive dosing (AUCtau),Apparent total body clearance after extravascular dosing (CL/F), Maximum observed concentration (Cmax), Time to reach Cmax (Tmax), Terminal elimination half-life (t1/2), Apparent volume of distribution during the terminal phase after single or repeated extravascular dosing (Vz/F), Peak Trough Ratio (PTR)
Pharmacokinetic profile of ASP1941 (urine): Aetau, Aetau%, Aelast, CLR
时间窗: Day 18 at pre-dose and from 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48, 48 to 72, 72 to 96 hours post-dose
Cumulative amount of drug or glucose excreted into urine over the time interval between consecutive dosing (Aetau ), Fraction of drug or glucose excreted into urine (Aetau) in % over the time interval between consecutive dosing (Aetau%)
次要结局
- Rate of glucose excretion per sampling interval(Day 1 and Day 18)
- Pharmacodynamic profile of urine glucose: Aelast and Aetau(Day 1 and Day 18)
- Rate of glucose excretion over 24 hours(Day 1 and Day 18)
- Pharmacodynamic profile of blood glucose: Cmax and AUCtau(Day -1 at -24, -23.75, -23.5, -23, -22.5, -22, -21, -20, -18, -16, -12, -8 and 0 (predose) hours prior to dose on Day 1 and on Day 18 predose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose)