Pharmacokinetic Study of ASP1517 With Kremezin®

Study Overview
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Brief Summary
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The objective of this study is to evaluate the effect of Kremezin® on the pharmacokinetics of single dose of ASP1517 in healthy non-elderly adult male subjects when administered concomitantly or in a time separated manner.

Official Title
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Pharmacokinetic Study of ASP1517 - Evaluation of the Effect of Kremezin® on the Pharmacokinetics of ASP1517 in Non-elderly Healthy Adult Male Subjects, When Administered Concomitantly or in a Time Separated Manner.

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: ASP1517
* Drug: Kremezin®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body weight (at screening): ≥50.0 kg and <80.0 kg Body-mass index (BMI) (at screening): ≥17.6 and <26.4 kg/m2 Subject must agree to use contraception consisting of two established forms (1 of which must be a barrier method) starting at the time of informed consent and continuing throughout the treatment period and for 84days after ASP1517 administration in the last period: Subject must agree not to donate sperm starting at the time of informed consent and continuing throughout 84 days after the last administration of ASP1517 in the last period. 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 the Period 1 (Day -1). Received or is scheduled to receive medications (including over-the-counter [OTC] drugs) within 7 days before the hospital admission day of the Period 1 (Day -1). Received or is scheduled to receive supplements within 7 days before the hospital admission day of the Period 1 (Day -1). Deviates from any of the normal range of blood pressure, pulse rate, body temperature and standard 12-lead electrocardiogram (ECG) specified at screening or the hospital admission day of the Period 1 (Day -1). Meets any of the following criteria for laboratory tests at screening or the hospital admission day of the Period 1 (Day -1). Normal ranges of each test specified at the study site or the test/assay organization will be used as the normal ranges in this study. Concurrent or previous drug allergies. Development of (an) upper gastrointestinal symptoms within seven days before the hospital admission day of the Period 1 (Day -1). Concurrent or previous hepatic disease, heart disease, respiratory disease, gastrointestinal disease, gastrointestinal obstruction,oesophageal varices, renal disease, endocrine disease, cerebrovascular disorder, malignant tumor, retinal neovascular lesions and macular edema. Concurrent chronic constipation or diarrhoea. 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Treatment arm includes 4 periods, single dose of ASP1517 alone, single dose of ASP1517 + Kremezin® without a time lag, single dose of ASP1517 + Kremezin® with a time lag (1 h before ASP1517 administration) and single dose of ASP1517 + Kremezin® with a time lag (1 h after ASP1517 administration) | Drug: ASP1517<br>* Oral<br>Drug: Kremezin®<br>* Oral<br>|
| Experimental: Group 2<br>Treatment arm includes 3 periods, single dose of ASP1517 alone, single dose of ASP1517 + Kremezin® with a time lag (2 h before ASP1517 administration) and single dose of ASP1517 + Kremezin® with a time lag (2 h after ASP1517 administration) | Drug: ASP1517<br>* Oral<br>Drug: Kremezin®<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: AUCinf | AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity | Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing | 
| PK parameter of ASP1517: Cmax | Cmax: Maximum concentration | Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameters of ASP1517: AUClast | AUClast: Area under the concentration-time curve from the time of dosing extrapolated to the last measurable concentration | Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing | 
| PK parameters of ASP1517: CL/F | CL/F: Apparent total systemic clearance | Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing | 
| PK parameters of ASP1517: t1/2 | t1/2: Terminal elimination half-life | Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing | 
| PK parameters of ASP1517: tmax | tmax: Time of Cmax | Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing | 
| PK parameters of ASP1517: tlag | tlag: Time point prior to the time point corresponding to the first measurable (non-zero) concentration | Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing | 
| PK parameters of ASP1517: Vz/F | Vz/F: Apparent volume of distribution during the terminal elimination phase | Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing | 
| Safety assessed by Adverse events |  | Up to 72 hours after final study drug dosing | 
| Safety assessed by Vital signs | Supine blood pressure, supine pulse rate and axillary body temperature | Up to 72 hours after each study drug dosing | 
| Safety assessed by Laboratory tests | Hematology, blood biochemistry and urinalysis | Up to 72 hours after each study drug dosing | 
| Safety assessed by Standard 12-lead ECG | ECG: Electrocardiogram | Up to 72 hours after each study drug dosing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ASP1517, Drug-drug interaction, Kremezin, Pharmacokinetics