Single and Multiple Dosing Study in Hemodialysis Patients With Hyperphosphatemia in Japan

NCT02510274 | Completed Phase 1

• 1 other identifier: 3325-CL-0003
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 5

Brief 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

Conditions

Chronic Kidney Disease; Hyperphosphatemia Undergoing Hemodialysis

Keywords

Hyperphosphatemia; ASP3325; Chronic Kidney Disease; pharmacodynamics; pharmacokinetics

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (12)

• Cmax of unchanged ASP3325

  Part 1 Before administration, Day 1, 2, 4, 5 and 7

• tmax of unchanged ASP3325

  Part 1 Before administration, Day 1, 2, 4, 5 and 7

• AUClast of ASP3325

  Part 1 Before administration, Day 1, 2, 4, 5 and 7

• AUCinf of ASP3325

  Part 1 Before administration, Day 1, 2, 4, 5 and 7

• t1/2 of ASP3325

  Part 1 Before administration, Day 1, 2, 4, 5 and 7

Study Arms (3)

Part1, ASP3325 Tablet A

EXPERIMENTAL

ASP3325 tablets A will be orally administered with 150 mL of water in fasting condition on non-dialysis day in Day 1

Drug: ASP3325

Part2, ASP3325 Tablet B group 1

EXPERIMENTAL

ASP3325 tablets B will be orally administered t.i.d. 30 minutes before each meal for 2 weeks

Drug: ASP3325

Part2, ASP3325 Tablet B group 2

EXPERIMENTAL

ASP3325 tablets B will be orally administered t.i.d. 30 minutes just after each meal for 2 weeks

Drug: ASP3325

Interventions

ASP3325 DRUG

oral

Part1, ASP3325 Tablet A; Part2, ASP3325 Tablet B group 1; Part2, ASP3325 Tablet B group 2

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (5)

Site: 4

Aichi, Japan

Location

Site: 5

Aichi, Japan

Location

Site: 1

Ibaraki, Japan

Location

Site: 2

Ibaraki, Japan

Location

Site: 3

Shizuoka, Japan

Location

Related Links

• Link to results on the Astellas Clinical Study Results website

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperphosphatemia

Interventions

ASP3325

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2015
• First Posted: July 29, 2015
• Study Start: May 12, 2014
• Primary Completion: November 4, 2014
• Study Completion: November 4, 2014
• Last Updated: November 5, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

JP (5)