Pharmacokinetic Study of ASP1517 With Kremezin®
- Registration Number
- NCT02693613
- Lead Sponsor
- Astellas Pharma Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 34
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group 1 ASP1517 Treatment arm includes 4 periods, single dose of ASP1517 alone, single dose of ASP1517 + Kremezin® without a time lag, single dose of ASP1517 + Kremezin® with a time lag (1 h before ASP1517 administration) and single dose of ASP1517 + Kremezin® with a time lag (1 h after ASP1517 administration) Group 1 Kremezin® Treatment arm includes 4 periods, single dose of ASP1517 alone, single dose of ASP1517 + Kremezin® without a time lag, single dose of ASP1517 + Kremezin® with a time lag (1 h before ASP1517 administration) and single dose of ASP1517 + Kremezin® with a time lag (1 h after ASP1517 administration) Group 2 ASP1517 Treatment arm includes 3 periods, single dose of ASP1517 alone, single dose of ASP1517 + Kremezin® with a time lag (2 h before ASP1517 administration) and single dose of ASP1517 + Kremezin® with a time lag (2 h after ASP1517 administration) Group 2 Kremezin® Treatment arm includes 3 periods, single dose of ASP1517 alone, single dose of ASP1517 + Kremezin® with a time lag (2 h before ASP1517 administration) and single dose of ASP1517 + Kremezin® with a time lag (2 h after ASP1517 administration)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
Safety assessed by Adverse events Up to 72 hours after final study drug dosing Safety assessed by Vital signs Up to 72 hours after each study drug dosing Supine blood pressure, supine pulse rate and axillary body temperature
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
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
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: 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
Trial Locations
- Locations (1)
Site JP00001
🇯🇵Tokyo, Japan