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Clinical Trial Details

Trial ID: L1014
Source ID: NCT02510274
Associated Drug: Asp3325
Title: Single and Multiple Dosing Study in Hemodialysis Patients With Hyperphosphatemia in Japan
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Kidney Disease|Hyperphosphatemia Undergoing Hemodialysis
Interventions: DRUG: ASP3325
Outcome Measures: Primary: Safety assessed by adverse events: Part 1, Up to Day 7|Safety assessed by adverse events: Part 2, Up to Day 22|Safety assessed by vital signs: Part 1, Vital signs include body temperature, blood pressure and pulse rate), Up to Day 7|Safety assessed by vital signs: Part 2, Vital signs include body temperature, blood pressure and pulse rate), Up to Day 22|Safety assessed by clinical laboratory test: Part 1, Clinical laboratory tests include hematology and biochemistry, Up to Day 7|Safety assessed by clinical laboratory test: Part 2, Clinical laboratory tests include hematology and biochemistry, Up to Day 22|Safety assessed by 12-Lead ECG: Part 1, ECG: electrocardiogram, Up to Day 7|Safety assessed by 12-Lead ECG: Part 2, ECG: electrocardiogram, Up to Day 22 | Secondary: Cmax of unchanged ASP3325, Cmax:maximum plasma concentration, Part 1 Before administration, Day 1, 2, 4, 5 and 7|tmax of unchanged ASP3325, tmax = time to reach maximum plasma concentration, Part 1 Before administration, Day 1, 2, 4, 5 and 7|AUClast of ASP3325, AUClast: Area under the Curve of plasma concentration during observation period in each observational day, Part 1 Before administration, Day 1, 2, 4, 5 and 7|AUCinf of ASP3325, AUCinf: Area under the Curve of plasma concentration, Part 1 Before administration, Day 1, 2, 4, 5 and 7|t1/2 of ASP3325, t1/2 = apparent terminal elimination half-life, Part 1 Before administration, Day 1, 2, 4, 5 and 7|Vz/F of ASP3325, Vz/F = apparent volume of distribution, Part 1 Before administration, Day 1, 2, 4, 5 and 7|CL/F of ASP3325, CL/F = oral clearance, Part 1 Before administration, Day 1, 2, 4, 5 and 7|Ctrough of ASP3325, Ctrough = observed trough concentration, Part 2 Before administration, Day 3, 5, 8, 10, 12, 15 and 22|Serum Pi of ASP3325, Serum Pi: serum phosphate concentration before dialysis, Part 2 Day -21, -14, and -7 in washout period, Day 1, 8, 15 and 22|Serum Calcium (adjusted for albumin), Corrected value of Calcium (Ca) (mg/dL) = Observed value of Ca (mg/dL) + \[4-albumin (g/dL), Part 2 Day -21, -14, and -7 in washout period, Day 1, 8, 15 and 22|Serum concentration of intact PTH before dialysis, PTH = parathyroid hormone, Part 2 Day -21 in washout period, Day 1, 8, 15 and 22|Serum concentration of FGF23, FGF23 = fibroblast growth factor 23, Part 2 Day -21 in washout period, Day 1, 8, 15 and 22
Sponsor/Collaborators: Sponsor: Astellas Pharma Inc
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-05-12
Completion Date: 2014-11-04
Results First Posted:
Last Update Posted: 2024-11-05
Locations: Site: 4, Aichi, Japan|Site: 5, Aichi, Japan|Site: 1, Ibaraki, Japan|Site: 2, Ibaraki, Japan|Site: 3, Shizuoka, Japan
URL: https://clinicaltrials.gov/show/NCT02510274