Healthy Subjects
Conditions
Keywords
Pharmacokinetics, ASP1517, Food effect
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.
Interventions
DRUGASP1517
Oral
Sponsors
Kyntra Bio
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 44 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 |
| 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 Plasma: CL/F | Up to Day 4 of each treatment period | CL/F: Apparent total systemic clearance |
Countries
Japan
Outcome results
None listed