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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02510274
Other study ID # 3325-CL-0003
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date May 12, 2014
Est. completion date November 4, 2014

Study information

Verified date October 2018
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

[Part 1] This part is an open-label, uncontrolled study to evaluate PK and safety with single dosing of ASP3325 in hemodialysis patients. After washout period of therapeutic medication for hyperphosphatemia, six subjects will receive single oral administration of ASP3325 (Tablet A) on a non-dialysis day (Day 1).

[Part 2] This part is a 2-arm, open-label, uncontrolled study to evaluate PD, PK and safety with dosing ASP3325 Tablet B t.i.d. before or just after each meal.

Eligible subjects at screening will be entered into the washout period for stopping their phosphate-binding treatment. 20 subjects with serum inorganic phosphorus (Pi) level between ≥6.0 and <10.0 mg/dL during the washout period (washout period week 1 or washout period week 2) will be randomized to each treatment group and ASP3325 will be administered for 2 weeks until Day 14.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ASP3325
oral

Locations

Country Name City State
Japan Site: 4 Aichi
Japan Site: 5 Aichi
Japan Site: 1 Ibaraki
Japan Site: 2 Ibaraki
Japan Site: 3 Shizuoka

Sponsors (1)

Lead Sponsor Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

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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