A Food Effect Study to Evaluate the Pharmacokinetics of ASP1517
- Registration Number
- NCT02805374
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 16
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description ASP1517 fasting then fed ASP1517 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. ASP1517 fed then fasting ASP1517 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.
- Primary Outcome Measures
Name Time Method Pharmacokinetics (PK) parameter of ASP1517 in Plasma: AUCinf Up to Day 4 of each treatment period AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity
PK parameter of ASP1517 in Plasma: Cmax Up to Day 4 of each treatment period Cmax: Maximum concentration
- Secondary Outcome Measures
Name Time Method PK parameter of ASP1517 in Plasma: CL/F Up to Day 4 of each treatment period CL/F: Apparent total systemic clearance
PK parameter of ASP1517 in Plasma: AUClast Up to Day 4 of each treatment period AUClast: Area under the concentration-time curve from the time of dosing to the last measurable concentration
PK parameter of ASP1517 in Plasma: λz Up to Day 4 of each treatment period λz: Terminal rate constant
PK parameter of ASP1517 in Plasma: MRTinf Up to Day 4 of each treatment period MRTinf: Mean residence time extrapolated to infinity
PK parameter of ASP1517 in Plasma: t1/2 Up to Day 4 of each treatment period t1/2: Terminal elimination half-life
PK parameter of ASP1517 in Plasma: tmax Up to Day 4 of each treatment period tmax: Time of Cmax
PK parameter of ASP1517 in Plasma: tlag Up to Day 4 of each treatment period tlag: Lag time
PK parameter of ASP1517 in Plasma: Vz/F Up to Day 4 of each treatment period Vz/F: Apparent volume of distribution during the terminal elimination phase
PK parameter of ASP1517 in Urine: Ae Up to Day 4 of each treatment period Ae: Cumulative amount of ASP1517 excreted into urine
PK parameter of ASP1517 in Urine: CLR Up to Day 4 of each treatment period CLR: Renal clearance
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 Up to Day 9 of Period 2 ECG: Electrocardiogram
Trial Locations
- Locations (1)
Site JP00001
🇯🇵Tokyo, Japan