Safety, Tolerability and Pharmacokinetic Study of ASP1517 in Healthy Non-elderly Male Volunteers

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the safety and tolerability of ASP1517 after single or multiple oral administration in healthy non-elderly adult male subjects.

Detailed Description
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The study consists of two parts, single and multiple dose. Within each part participants will be randomized to either ASP1517 or placebo.

Official Title
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ASP1517 Phase 1 Clinical Study - Single and Multiple Oral Dosing of ASP1517 in Healthy Non-elderly Male Volunteers

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: ASP1517
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body weight: ≥50.0 kg, <80.0 kg BMI: ≥18.5 kg/m2, <25.0 kg/m2 Eligible, as judged by the investigator/subinvestigator based on the results of physical examinations (subjective symptoms and objective findings) and all tests obtained at screening and up to the timing immediately before study medication Supine blood pressure: Systolic blood pressure ≥90 mmHg, ≤130 mmHg; Diastolic blood pressure ≤85 mmHg Pulse rate at rest in supine position: ≥40 bpm, <100 bpm Exclusion Criteria: Received any investigational drugs in other clinical or post-marketing studies within 120 days before the screening assessment Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the screening assessment Received medication within 7 days before hospital admission or is scheduled to receive medication History of drug allergies Upper gastrointestinal disease (e.g. nausea, vomiting, stomachache) within 7 days before the study Excessive smoking or drinking habit (measure of excessive: alcohol: 45 g/day, smoking: 20 cigarettes/day)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 44 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1<br>single administration | Drug: ASP1517<br>* oral<br>* Other names: FG-4592;Drug: Placebo<br>* oral<br>|
| Experimental: Part 2<br>multiple administration | Drug: ASP1517<br>* oral<br>* Other names: FG-4592;Drug: Placebo<br>* oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of ASP1517 |  | During 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of ASP1517 |  | During 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, Safety and tolerability, Plasma concentration, ASP1517, FG-4592