Healthy Volunteers
Conditions
Keywords
Drug-drug interaction, Kremezin, Pharmacokinetics, ASP1517
Brief summary
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.
Interventions
DRUGASP1517
Oral
DRUGKremezin®
Oral
Sponsors
Kyntra Bio
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
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 (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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK) parameter of ASP1517: AUCinf | Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing | AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity |
| PK parameter of ASP1517: Cmax | Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing | Cmax: Maximum concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK parameters of ASP1517: t1/2 | Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing | t1/2: Terminal elimination half-life |
| PK parameters of ASP1517: tmax | Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing | tmax: Time of Cmax |
| PK parameters of ASP1517: tlag | Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing | tlag: Time point prior to the time point corresponding to the first measurable (non-zero) concentration |
| PK parameters of ASP1517: Vz/F | Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing | Vz/F: Apparent volume of distribution during the terminal elimination phase |
| PK parameters of ASP1517: AUClast | Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing | AUClast: Area under the concentration-time curve from the time of dosing extrapolated to the last measurable concentration |
| Safety assessed by Vital signs | Up to 72 hours after each study drug dosing | Supine blood pressure, supine pulse rate and axillary body temperature |
| Safety assessed by Laboratory tests | Up to 72 hours after each study drug dosing | Hematology, blood biochemistry and urinalysis |
| Safety assessed by Standard 12-lead ECG | Up to 72 hours after each study drug dosing | ECG: Electrocardiogram |
| Safety assessed by Adverse events | Up to 72 hours after final study drug dosing | — |
| PK parameters of ASP1517: CL/F | Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing | CL/F: Apparent total systemic clearance |
Countries
Japan
Outcome results
None listed