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

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT02531204

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

9.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Urine Phosphorus Excretion	Drug: ASP1585	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Official Title:

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

Study Start Date :

Aug 1, 2014

Actual Primary Completion Date :

Feb 1, 2015

Actual Study Completion Date :

Feb 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Average daily amount of urine phosphorus change from baseline [Day 5 to Day 8 after start of each dosing]
Average daily amount of urine phosphorus on Day 5 to Day 8 was compared with that on Day -4 to Day 1 (baseline)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 44 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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