A Food Effect Study to Evaluate the Pharmacokinetics of ASP1517

Study Overview
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Brief Summary
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The objective of this study is to evaluate the effect of food on the pharmacokinetics of a single oral dose of ASP1517 in non-elderly healthy adult male subjects.

Official Title
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ASP1517 Pharmacokinetic Study - Evaluation of Food Effect on the Pharmacokinetics of ASP1517

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: ASP1517


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body weight: ≥50.0 kg and <80.0 kg Body-mass index : ≥17.6 and <26.4 kg/m2 Subject must agree to use two of the established contraceptive methods after informed consent acquisition through 84 days after the last administration of the study drug. Subject must agree not to donate sperm after informed consent acquisition through 84 days after the last administration of the study drug. Exclusion Criteria: Received or is scheduled to receive any investigational drugs in other clinical trials or post-marketing studies within 120 days before screening or during the period from screening to the hospital admission day of Period 1 Received or is scheduled to receive medications (including over-the-counter [OTC] drugs) within 7 days before the hospital admission day of Period 1 Received or is scheduled to receive supplements within 7 days before the hospital admission day of the Period 1 Deviates from any of the normal range of blood pressure, pulse rate, body temperature and standard 12-lead electrocardiogram (ECG) at screening or the hospital admission day of Period 1 Meets any of the criteria for laboratory tests at screening or the hospital admission day of Period 1. Normal ranges of each test specified at the test/assay organization will be used as the normal ranges in this study. Concurrent or previous drug allergies. Development of (an) upper gastrointestinal symptom(s) within seven days before the hospital admission day of Period 1. Concurrent or previous hepatic disease, heart disease, respiratory disease, gastrointestinal disease, renal disease, endocrine disease, cerebrovascular disorder, malignant tumor, retinal neovascular lesions and macular edema. A history of digestive tract excision. Previous use of hypoxia inducible factor-prolyl hydroxylase inhibitors (HIF-PHI) such as ASP1517 (FG-4592), YM311(FG-2216) or erythropoietin products. Excessive alcohol or smoking habit.

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

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASP1517 fasting then fed<br>Subjects will receive a single oral dose of ASP1517 under fasting conditions in period 1, then subjects will receive a single oral dose of ASP1517 under fed conditions in period 2. | Drug: ASP1517<br>* Oral<br>|
| Experimental: ASP1517 fed then fasting<br>Subjects will receive a single oral dose of ASP1517 under fed conditions in period 1, then subjects will receive a single oral dose of ASP1517 under fasting conditions in period 2. | Drug: ASP1517<br>* Oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK) parameter of ASP1517 in Plasma: AUCinf | AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity | Up to Day 4 of each treatment period | 
| PK parameter of ASP1517 in Plasma: Cmax | Cmax: Maximum concentration | Up to Day 4 of each treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameter of ASP1517 in Plasma: AUClast | AUClast: Area under the concentration-time curve from the time of dosing to the last measurable concentration | Up to Day 4 of each treatment period | 
| PK parameter of ASP1517 in Plasma: CL/F | CL/F: Apparent total systemic clearance | Up to Day 4 of each treatment period | 
| PK parameter of ASP1517 in Plasma: λz | λz: Terminal rate constant | Up to Day 4 of each treatment period | 
| PK parameter of ASP1517 in Plasma: MRTinf | MRTinf: Mean residence time extrapolated to infinity | Up to Day 4 of each treatment period | 
| PK parameter of ASP1517 in Plasma: t1/2 | t1/2: Terminal elimination half-life | Up to Day 4 of each treatment period | 
| PK parameter of ASP1517 in Plasma: tmax | tmax: Time of Cmax | Up to Day 4 of each treatment period | 
| PK parameter of ASP1517 in Plasma: tlag | tlag: Lag time | Up to Day 4 of each treatment period | 
| PK parameter of ASP1517 in Plasma: Vz/F | Vz/F: Apparent volume of distribution during the terminal elimination phase | Up to Day 4 of each treatment period | 
| PK parameter of ASP1517 in Urine: Ae | Ae: Cumulative amount of ASP1517 excreted into urine | Up to Day 4 of each treatment period | 
| PK parameter of ASP1517 in Urine: CLR | CLR: Renal clearance | Up to Day 4 of each treatment period | 
| Safety assessed by adverse events |  | Up to Day 9 of Period 2 | 
| Number of participants with abnormal vital signs and/or adverse events during treatment period |  | Up to Day 9 of Period 2 | 
| Number of participants with abnormal laboratory values and/or adverse events during treatment period |  | Up to Day 9 of Period 2 | 
| Number of participants with abnormal standard 12-Lead ECG and/or adverse events during treatment period | ECG: Electrocardiogram | Up to Day 9 of Period 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, ASP1517, Food effect