Study to Evaluate the Safety and Pharmacokinetics of ASP2151 in Healthy Non-elderly and Elderly Subjects
- Registration Number
- NCT02796118
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
The objective of this study is to evaluate the safety and the pharmacokinetics of ASP2151 after multiple oral dosing of ASP2151 in healthy non-elderly male and elderly male Japanese subjects, and to compare the pharmacokinetics of ASP2151 in healthy non-elderly male and elderly male Japanese subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 36
Inclusion Criteria
- Body weight: ≥50.0 kg and <85.0 kg
- Body mass index (BMI): ≥17.6 and <26.4 kg/m2
Exclusion Criteria
- Subjects with a complication of any diseases
- Subjects with a history of hepatic disease
- Subjects with a history of heart disease
- Subjects with a history of respiratory disease
- Subjects with a history of alimentary disease
- Subjects with a history of renal disease
- Subjects with a history of cerebrovascular disorder
- Subjects with a history of malignant tumor
- Subjects with a history of drug allergies or allergies disorders excluding pollinosis
- Subjects with a history of drug dependency or alcohol dependence syndrome
- Subjects who developed genital herpes or herpes zoster within 90 days before the initial dosing
- Subjects who do not meet any of the criteria for laboratory tests
- Subjects who received medications within 14 days before the initial dosing.
- Subjects who received any investigational drugs in other clinical trials or post-marketing studies within 120 days before screening or the initial dosing
- Excessive alcohol drinking or smoking habit
- Subjects who previously received administration of ASP2151 (including placebo)
- Abnormalities detected on an ophthalmological examination
- Subjects who deviate from the normal range of standard 12-lead ECG at screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ASP2151 Low dose in non-elderly subjects group ASP2151 Subjects will receive ASP2151 daily on Days 1 to 7. Placebo in elderly subjects group Placebo Subjects will receive matching placebo daily on Days 1 to 7. Placebo in non-elderly subjects group Placebo Subjects will receive matching placebo daily on Days 1 to 7. ASP2151 Low dose in elderly subjects group ASP2151 Subjects will receive ASP2151 daily on Days 1 to 7. ASP2151 High dose in elderly subjects group ASP2151 Subjects will receive ASP2151 daily on Days 1 to 7. ASP2151 High dose in non-elderly subjects group ASP2151 Subjects will receive ASP2151 daily on Days 1 to 7.
- Primary Outcome Measures
Name Time Method Safety assessed by vital sign measurement: supine pulse rate Up to Day 14 Pharmacokinetics of ASP2151 in plasma: CL/F Up to Day 9 CL/F: Apparent total systemic clearance
Pharmacokinetics of ASP2151 in urine: Ae Up to Day 9 Ae: Amount excreted in urine
Safety assessed by Vital sign measurement: axillary body temperature Up to Day 14 Safety assessed by Standard 12-lead electrocardiogram for QT assessment Up to Day 14 Safety assessed by ophthalmological examination Up to Day 14 Pharmacokinetics of ASP2151 in plasma: C24 Up to Day 9 C24: Concentration at 24hours after dosing
Pharmacokinetics of ASP2151 in urine: Cumulative Ae Up to Day 9 Pharmacokinetics of ASP2151 in urine: CLR Up to Day 9 CLR: Renal clearance
Safety assessed by laboratory test: urinalysis Up to Day 14 Pharmacokinetics of ASP2151 in plasma: tmax Up to Day 9 tmax: The time after dosing when Cmax occurs
Pharmacokinetics of ASP2151 in urine: Ae% Up to Day 9 Ae%: Percent of ASP2151 amount excreted in urine
Pharmacokinetics of ASP2151 in urine: Cumulative Ae% Up to Day 9 Safety assessed by laboratory test: blood biochemistry Up to Day 14 Safety assessed by vital sign measurement: supine blood pressure Up to Day 14 Safety assessed by Standard 12-lead electrocardiogram Up to Day 14 Safety assessed by incidence of adverse events Up to Day 14 Pharmacokinetics of ASP2151 in plasma: t1/2 Up to Day 9 t1/2: Apparent terminal elimination half-life
Pharmacokinetics of ASP2151 in plasma: AUCinf Up to Day 9 AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity
Safety assessed by laboratory test: Hematology Up to Day 14 Pharmacokinetics of ASP2151 in plasma: Cmax Up to Day 9 Cmax: Maximum concentration
Pharmacokinetics of ASP2151 in plasma: AUC24 Up to Day 9 AUC24: Area under the concentration-time curve from the time of dosing to 24hours after dosing
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Site JP00001
🇯🇵Osaka, Japan