Chronic Kidney Disease Clinical Trial
Official title:
A Phase 1, Single and Multiple Dosing Study to Evaluate Pharmacokinetics and Pharmacodynamics of ASP3325 in Patients With Chronic Kidney Disease and Hyperphosphatemia Undergoing Hemodialysis
Verified date | October 2018 |
Source | Astellas Pharma Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this study is to assess PK, safety and tolerability of a single oral dose of ASP3325 and to assess PD, PK and safety of repeated oral doses of ASP3325 administered t.i.d. before or just after each meal
Status | Completed |
Enrollment | 24 |
Est. completion date | November 4, 2014 |
Est. primary completion date | November 4, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 74 Years |
Eligibility |
Inclusion Criteria: - Subject who has received maintenance hemodialysis 3 times a week for at least 12 weeks (84 days) prior to the scheduled first day of the washout period. - Subject who can receive morning dialysis from the start of the washout period to the end of follow-up period. (Part 2) - Subject with pre-dialysis serum Pi level between =6.0 and <10.0 mg/dL and be confirmed increase in serum Pi of =1.5 mg/dL after the maximum dialysis interval at the washout period week 1 or 2. (Part 2) - Subject who did not change the type or dose of any phosphate binder(s), any nutritional supplements or any other drugs with phosphorus reducing action for at least 4 weeks (28 days) prior to the scheduled first day of the washout period. - Subject who did not receive calcimimetics (e.g., cinacalcet HCl) for at least 12 weeks (84 days) prior to the scheduled first day of the washout period. - Subject taking native or active vitamin D (including vitamin D analogues), calcitonin agents or PTH agents must be on stable dose for at least 4 weeks (28 days) prior to the scheduled first day of the washout period. Exclusion Criteria: - Subject who has a history of severe gastrointestinal disorder, major gastrointestinal surgery, malabsorption considered influential on the absorption of the drug and nutrition in the gastrointestinal tract. - Subject who has a history of parathyroid intervention (e.g., parathyroidectomy [PTx], percutaneous ethanol injection therapy [PEIT]). - Subject whose dry weight loss >5% within 12 weeks (84 days) prior to the scheduled start day of the washout period. - Confirmed serum intact PTH >1000 pg/mL at the start of the washout period (only applicable for Part 2). - Subject whose last 3 measurement values at the separate day of pre-dialysis systolic/diastolic blood pressure before the scheduled start day of the washout period or during the washout period are all 180 mmHg or higher and 120 mmHg or higher. - Subject who has severe congestive heart failure (i.e., NYHA cardiac function classification Class III or severer). - Subject who experienced a myocardial infarction or major surgery excluding vascular access surgery within 12 weeks (84 days) prior to the informed consent signing. - Subject who has any of liver function tests (ALT, AST, T-Bil) out of range as indicated below at the screening (Part 1) or during the washout period, or patients with a complication of serious hepatic disease (e.g., acute and active chronic hepatitis, liver cirrhosis). AST: >2×ULN, ALT: >2×ULN, T-Bil: >1.25×ULN - Subject with history or complication of malignant tumor (considered eligible if recurrence has not been observed for at least 5 years). - Subject with history of serious drug hypersensitivity, such as anaphylactic shock. |
Country | Name | City | State |
---|---|---|---|
Japan | Site: 4 | Aichi | |
Japan | Site: 5 | Aichi | |
Japan | Site: 1 | Ibaraki | |
Japan | Site: 2 | Ibaraki | |
Japan | Site: 3 | Shizuoka |
Lead Sponsor | Collaborator |
---|---|
Astellas Pharma Inc |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety assessed by adverse events: Part 1 | Up to Day 7 | ||
Primary | Safety assessed by adverse events: Part 2 | Up to Day 22 | ||
Primary | Safety assessed by vital signs: Part 1 | Vital signs include body temperature, blood pressure and pulse rate) | Up to Day 7 | |
Primary | Safety assessed by vital signs: Part 2 | Vital signs include body temperature, blood pressure and pulse rate) | Up to Day 22 | |
Primary | Safety assessed by clinical laboratory test: Part 1 | Clinical laboratory tests include hematology and biochemistry | Up to Day 7 | |
Primary | Safety assessed by clinical laboratory test: Part 2 | Clinical laboratory tests include hematology and biochemistry | Up to Day 22 | |
Primary | Safety assessed by 12-Lead ECG: Part 1 | ECG: electrocardiogram | Up to Day 7 | |
Primary | 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 | |
Secondary | tmax of unchanged ASP3325 | tmax = time to reach maximum plasma concentration | Part 1 Before administration, Day 1, 2, 4, 5 and 7 | |
Secondary | 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 | |
Secondary | AUCinf of ASP3325 | AUCinf: Area under the Curve of plasma concentration | Part 1 Before administration, Day 1, 2, 4, 5 and 7 | |
Secondary | t1/2 of ASP3325 | t1/2 = apparent terminal elimination half-life | Part 1 Before administration, Day 1, 2, 4, 5 and 7 | |
Secondary | Vz/F of ASP3325 | Vz/F = apparent volume of distribution | Part 1 Before administration, Day 1, 2, 4, 5 and 7 | |
Secondary | CL/F of ASP3325 | CL/F = oral clearance | Part 1 Before administration, Day 1, 2, 4, 5 and 7 | |
Secondary | Ctrough of ASP3325 | Ctrough = observed trough concentration | Part 2 Before administration, Day 3, 5, 8, 10, 12, 15 and 22 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Serum concentration of intact PTH before dialysis | PTH = parathyroid hormone | Part 2 Day -21 in washout period, Day 1, 8, 15 and 22 | |
Secondary | Serum concentration of FGF23 | FGF23 = fibroblast growth factor 23 | Part 2 Day -21 in washout period, Day 1, 8, 15 and 22 |
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