Healthy Subjects
Conditions
Keywords
ASP1517, Pharmacokinetics, Drug-drug interaction
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.
Interventions
DRUGASP1517
Oral dose
DRUGLanthanum carbonate hydrate
Oral dose
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 (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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK) parameter of ASP1517 in plasma: AUCINF | Up to 72hr after each dosing | AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity |
| PK parameter of ASP1517 in plasma: AUC24h | Up to 72hr after each dosing | AUC24h: Area under the concentration-time curve from the time of dosing to 24h |
| PK parameter of ASP1517 in plasma: Cmax | Up to 72hr after each dosing | Cmax: Maximum concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK parameter of ASP1517 in plasma: Lambda z | Up to 72hr after each dosing | Lambda z: Terminal elimination rate constant |
| PK parameter of ASP1517 in plasma: MRTinf | Up to 72hr after each dosing | MRTinf: Mean residence time from the time of dosing extrapolated to time infinity |
| PK parameter of ASP1517 in plasma: tmax | Up to 72hr after each dosing | tmax : Time of Cmax |
| PK parameter of ASP1517 in plasma: tlag | Up to 72hr after each dosing | tlag: Time point prior to the time point corresponding to the first measurable (non-zero) concentration |
| PK parameter of ASP1517 in plasma: Vz/F | Up to 72hr after each dosing | Vz/F: Apparent volume of distribution during the terminal elimination phase after single extra-vascular dosing |
| Safety assessed by incidence of adverse events | Up to 7 days after drug dosing of period 2 | — |
| PK parameter of ASP1517 in plasma: AUClast | Up to 72hr after each dosing | AUC last: Area under the concentration-time curve from the time of dosing to the last measurable concentration |
| 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 | — |
| Safety assessed by supine blood pressure | Up to 7 days after drug dosing of period 2 | — |
| PK parameter of ASP1517 in plasma: CL/F | Up to 72hr after each dosing | CL/F: Apparent total systemic clearance |
| PK parameter of ASP1517 in plasma: t1/2 | Up to 72hr after each dosing | t1/2: Terminal elimination half-life |
Countries
Japan
Outcome results
None listed