Study to Evaluate the Safety and Pharmacokinetics of ASP2151 in Healthy Non-elderly and Elderly Subjects

Study Overview
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Brief Summary
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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.

Official Title
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ASP2151 Phase 1 Study - Multiple Oral Dosing Study in Healthy Non-elderly Male and Elderly Male Japanese Subjects-

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: ASP2151
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASP2151 Low dose in non-elderly subjects group<br>Subjects will receive ASP2151 daily on Days 1 to 7. | Drug: ASP2151<br>* Oral<br>|
| Experimental: ASP2151 High dose in non-elderly subjects group<br>Subjects will receive ASP2151 daily on Days 1 to 7. | Drug: ASP2151<br>* Oral<br>|
| Experimental: ASP2151 Low dose in elderly subjects group<br>Subjects will receive ASP2151 daily on Days 1 to 7. | Drug: ASP2151<br>* Oral<br>|
| Experimental: ASP2151 High dose in elderly subjects group<br>Subjects will receive ASP2151 daily on Days 1 to 7. | Drug: ASP2151<br>* Oral<br>|
| Placebo Comparator: Placebo in non-elderly subjects group<br>Subjects will receive matching placebo daily on Days 1 to 7. | Drug: Placebo<br>* Oral<br>|
| Placebo Comparator: Placebo in elderly subjects group<br>Subjects will receive matching placebo daily on Days 1 to 7. | Drug: Placebo<br>* Oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of ASP2151 in plasma: Cmax | Cmax: Maximum concentration | Up to Day 9 | 
| Pharmacokinetics of ASP2151 in plasma: tmax | tmax: The time after dosing when Cmax occurs | Up to Day 9 | 
| Pharmacokinetics of ASP2151 in plasma: t1/2 | t1/2: Apparent terminal elimination half-life | Up to Day 9 | 
| Pharmacokinetics of ASP2151 in plasma: C24 | C24: Concentration at 24hours after dosing | Up to Day 9 | 
| Pharmacokinetics of ASP2151 in plasma: AUC24 | AUC24: Area under the concentration-time curve from the time of dosing to 24hours after dosing | Up to Day 9 | 
| Pharmacokinetics of ASP2151 in plasma: AUCinf | AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity | Up to Day 9 | 
| Pharmacokinetics of ASP2151 in plasma: CL/F | CL/F: Apparent total systemic clearance | Up to Day 9 | 
| Pharmacokinetics of ASP2151 in urine: Ae | Ae: Amount excreted in urine | Up to Day 9 | 
| Pharmacokinetics of ASP2151 in urine: Cumulative Ae |  | Up to Day 9 | 
| Pharmacokinetics of ASP2151 in urine: Ae% | Ae%: Percent of ASP2151 amount excreted in urine | Up to Day 9 | 
| Pharmacokinetics of ASP2151 in urine: Cumulative Ae% |  | Up to Day 9 | 
| Pharmacokinetics of ASP2151 in urine: CLR | CLR: Renal clearance | Up to Day 9 | 
| Safety assessed by laboratory test: Hematology |  | Up to Day 14 | 
| Safety assessed by laboratory test: blood biochemistry |  | Up to Day 14 | 
| Safety assessed by laboratory test: urinalysis |  | Up to Day 14 | 
| Safety assessed by Vital sign measurement: axillary body temperature |  | Up to Day 14 | 
| Safety assessed by vital sign measurement: supine blood pressure |  | Up to Day 14 | 
| Safety assessed by vital sign measurement: supine pulse rate |  | Up to Day 14 | 
| Safety assessed by Standard 12-lead electrocardiogram |  | 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 | 
| Safety assessed by incidence of adverse events |  | Up to Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, Healthy non-elderly and elderly subjects, ASP2151, Safety