A Study of ASP1585 to Evaluate the Bioequivalence Between ASP1585 Granules and ASP1585 Capsules

Pharmacodynamic Study of ASP1585 - Verification of Bioequivalence Between ASP1585 Granules and ASP1585 Capsules

The purpose of this study is to assess the bioequivalence between ASP1585 granules and ASP1585 capsules after repeated oral administration of ASP1585 granules or ASP1585 capsules under open-label conditions in non-elderly healthy male subjects. In addition, the safety of these products is assessed.

Study Overview

• Status: Completed
• Conditions: Healthy; Urine Phosphorus Excretion
• Intervention / Treatment: Drug: ASP1585

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Kagoshima, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 44 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Body weight (at screening) ≥ 50.0 kg and < 80.0 kg
• Body mass index (BMI) (at screening) ≥ 17.6 kg/m2 and < 26.4 kg/m2
• Healthy, as judged by the investigator/sub-investigator based on medical history and the results of physical examination (subjective symptoms and objective findings) and all tests obtained at screening and during the period from hospital admission to immediately before study medication in 1st period.

Exclusion Criteria:

• Received or scheduled to receive any investigational drugs in other clinical trials, post-marketing studies, or clinical studies within 120 days before the screening or during the period from the screening to 1st hospitalization.
• Donated or scheduled to donate 400 mL of whole blood within 90 days before the screening or during the period from the screening to 1st hospitalization, 200 mL of whole blood within 30 days before the screening or during the period from the screening to 1st hospitalization, or blood components within 14 days before the screening or during the period from the screening to 1st hospitalization.
• Any deviation of the laboratory tests at screening or 1st hospitalization.

• A deviation from the normal range of blood pressure, pulse rate, or body temperature at screening or 1st hospitalization

  • Sitting blood pressure: Systolic blood pressure: ≥90 mmHg, ≤140 mmHg; Diastolic blood pressure: ≥40 mmHg, ≤90 mmHg
  • Sitting pulse rate; ≥40 bpm, ≤99 bpm
  • Axillary body temperature; ≥35.0°C, ≤37.0°C
• History of drug allergies
• Upper gastrointestinal disease (e.g., nausea, vomiting, and stomachache) within 7 days before 1st hospitalization
• Concurrent or previous hepatic disease (e.g., viral hepatitis, drug-induced liver injury, and hepatic impairment)
• Concurrent or previous heart disease (e.g., congestive heart failure, angina pectoris, and arrhythmia requiring treatment)
• Concurrent or previous GI disease (e.g., ileus paralytic, gastric atony, intestinal atony, colitis ulcerative, peptic ulcer and gastroesophageal reflux esophagitis; except for a history of appendicitis).
• Concurrent or previous renal disease (e.g., acute renal failure, glomerulonephritis, and interstitial nephritis)
• Concurrent or previous renal disease (e.g., acute renal failure, glomerulonephritis, and interstitial nephritis)
• Concurrent or previous cerebrovascular disorder (e.g., cerebral infarction)
• Previous use of bixalomer
• Excessive smoking or drinking habit

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ASP1585 granules preceding group	Drug: ASP1585; oral; Other Names: Bixalomer; Kiklin
Active Comparator: ASP1585 capsules preceding group	Drug: ASP1585; oral; Other Names: Bixalomer; Kiklin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average daily amount of urine phosphorus change from baseline	Average daily amount of urine phosphorus on Day 5 to Day 8 was compared with that on Day -4 to Day 1 (baseline)	Day 5 to Day 8 after start of each dosing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety profile assessed by the incidence of adverse events, vital signs, clinical laboratory tests, and 12-lead ECG	ECG: Electrocardiogram	Up to Day 17 on Period 2

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: August 12, 2015
• First Submitted That Met QC Criteria: August 20, 2015
• First Posted (Estimate): August 24, 2015

Study Record Updates

• Last Update Posted (Estimate): August 24, 2015
• Last Update Submitted That Met QC Criteria: August 20, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Bioequivalence; Pharmacodynamic; ASP1585; Phosphate binder; Bixalomer; urinary phosphorus excretion
• Other Study ID Numbers: 1585-CL-0201