A Drug Interaction Study to Evaluate the Pharmacokinetics of ASP1517 and Lanthanum Carbonate Hydrate
Phase 1
Completed
- Conditions
- Healthy Subjects
- Interventions
- Registration Number
- NCT02952040
- Lead Sponsor
- Astellas Pharma Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 18
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description ASP1517+lanthanum period preceding group ASP1517 Subjects will receive a single oral dose of ASP1517 with lanthanum carbonate hydrate in period 1, then subjects will receive a single oral dose of ASP1517 alone in period 2. ASP1517 alone period preceding group ASP1517 Subjects will receive a single oral dose of ASP1517 alone in period 1, then subjects will receive a single oral dose of ASP1517 with lanthanum carbonate hydrate in period 2. ASP1517 alone period preceding group Lanthanum carbonate hydrate Subjects will receive a single oral dose of ASP1517 alone in period 1, then subjects will receive a single oral dose of ASP1517 with lanthanum carbonate hydrate in period 2. ASP1517+lanthanum period preceding group Lanthanum carbonate hydrate Subjects will receive a single oral dose of ASP1517 with lanthanum carbonate hydrate in period 1, then subjects will receive a single oral dose of ASP1517 alone in period 2.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method PK parameter of ASP1517 in plasma: tmax Up to 72hr after each dosing tmax : Time of Cmax
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
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
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 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: 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 Safety assessed by supine blood pressure Up to 7 days after drug dosing of period 2 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
Trial Locations
- Locations (1)
Site JP00001
🇯🇵Tokyo, Japan