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

NCT ID: NCT02531204

Last Updated: 2015-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2015-02-28

Brief Summary

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.

Conditions

Healthy; Urine Phosphorus Excretion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

ASP1585 granules preceding group

Group Type: EXPERIMENTAL

ASP1585

Intervention Type: DRUG

oral

ASP1585 capsules preceding group

Group Type: ACTIVE_COMPARATOR

ASP1585

Intervention Type: DRUG

oral

Interventions

ASP1585

oral

Intervention Type: DRUG

Other Intervention Names

Bixalomer; Kiklin

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

Kagoshima, , Japan

Countries

Japan

Other Identifiers

1585-CL-0201

Identifier Type: -

Identifier Source: org_study_id