A Drug Interaction Study to Evaluate the Pharmacokinetics of ASP1517 and Lanthanum Carbonate Hydrate

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the effect of lanthanum carbonate hydrate on the pharmacokinetics (PK) of ASP1517 in non-elderly healthy male subjects.

Official Title
-----------------
Pharmacokinetic Study of ASP1517 - Evaluation of the Effect of Lanthanum Carbonate Hydrate on the Pharmacokinetics of ASP1517 in Non-elderly Healthy Adult Male Subjects -

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: ASP1517
* Drug: Lanthanum carbonate hydrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body weight (at screening): ≥50.0 kg and <80.0 kg Body-mass index (at screening): ≥17.6 and <26.4 kg/m2 [Body-mass index = Body weight (kg)/(Height (m))2] Subject must agree to use contraception consisting of two established forms specified below starting at the time of informed consent and continuing throughout the treatment period and for 84 days after the last administration of ASP1517. 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. 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. Received or is scheduled to receive medications (including over-the-counter drugs) or 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 at screening or the hospital admission day of the Period 1. Meets any of the following criteria for laboratory tests at screening or the hospital admission day of the Period 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 symptom(s) within 7 days before the hospital admission day of the Period 1. Concurrent or previous hepatic disease, heart disease, respiratory disease, peritoneum inflammation. A history of abdominal surgery, digestive tract excision. Concurrent or previous renal disease, endocrine disease, cerebrovascular disorder, malignant tumor, retinal neovascular lesions. Previous use of hypoxia inducible factor-prolyl hydroxylase inhibitors (HIF-PHI) such as ASP1517 (FG-4592), YM311 (FG-2216), erythropoietin products or lanthanum carbonate hydrate. Excessive alcohol or smoking habit.

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

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

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 alone period preceding group<br>Subjects will receive a single oral dose of ASP1517 alone in period 1, then subjects will receive a single oral dose of ASP1517 with lanthanum carbonate hydrate in period 2. | Drug: ASP1517<br>* Oral dose<br>Drug: Lanthanum carbonate hydrate<br>* Oral dose<br>* Other names: Fosrenol;|
| Experimental: ASP1517+lanthanum period preceding group<br>Subjects will receive a single oral dose of ASP1517 with lanthanum carbonate hydrate in period 1, then subjects will receive a single oral dose of ASP1517 alone in period 2. | Drug: ASP1517<br>* Oral dose<br>Drug: Lanthanum carbonate hydrate<br>* Oral dose<br>* Other names: Fosrenol;|

What is the study measuring?
-----------------
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 72hr after each dosing | 
| PK parameter of ASP1517 in plasma: AUC24h | AUC24h: Area under the concentration-time curve from the time of dosing to 24h | Up to 72hr after each dosing | 
| PK parameter of ASP1517 in plasma: Cmax | Cmax: Maximum concentration | Up to 72hr after each dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameter of ASP1517 in plasma: AUClast | AUC last: Area under the concentration-time curve from the time of dosing to the last measurable concentration | Up to 72hr after each dosing | 
| PK parameter of ASP1517 in plasma: CL/F | CL/F: Apparent total systemic clearance | Up to 72hr after each dosing | 
| PK parameter of ASP1517 in plasma: t1/2 | t1/2: Terminal elimination half-life | Up to 72hr after each dosing | 
| PK parameter of ASP1517 in plasma: Lambda z | Lambda z: Terminal elimination rate constant | Up to 72hr after each dosing | 
| PK parameter of ASP1517 in plasma: MRTinf | MRTinf: Mean residence time from the time of dosing extrapolated to time infinity | Up to 72hr after each dosing | 
| PK parameter of ASP1517 in plasma: tmax | tmax : Time of Cmax | Up to 72hr after each dosing | 
| PK parameter of ASP1517 in plasma: tlag | tlag: Time point prior to the time point corresponding to the first measurable (non-zero) concentration | Up to 72hr after each dosing | 
| PK parameter of ASP1517 in plasma: Vz/F | Vz/F: Apparent volume of distribution during the terminal elimination phase after single extra-vascular dosing | Up to 72hr after each dosing | 
| Safety assessed by incidence of adverse events |  | Up to 7 days after drug dosing of period 2 | 
| Safety assessed by supine blood pressure |  | Up to 7 days after drug dosing of period 2 | 
| Safety assessed by supine pulse rate |  | Up to 7 days after drug dosing of period 2 | 
| Safety assessed by axillary body temperature |  | Up to 7 days after drug dosing of period 2 | 
| Safety assessed by Laboratory tests: Hematology |  | Up to 7 days after drug dosing of period 2 | 
| Safety assessed by Laboratory tests: Blood biochemistry |  | Up to 7 days after drug dosing of period 2 | 
| Safety assessed by Laboratory tests: Urinalysis |  | Up to 7 days after drug dosing of period 2 | 
| Safety assessed by 12-lead electrocardiogram |  | Up to 7 days after drug dosing of period 2 | 

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