Clinical trial NCT02531204: A Study of ASP1585 to Evaluate the Bioequivalence Between ASP1585 Granules and ASP1585 Capsules
Official title: Pharmacodynamic Study of ASP1585 - Verification of Bioequivalence Between ASP1585 Granules and ASP1585 Capsules
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Urine Phosphorus Excretion
Keywords: ASP1585
Bioequivalence
Pharmacodynamic
Phosphate binder
Bixalomer
urinary phosphorus excretion
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2015-08-24
Enrollment: 60
Sex: MALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.


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

Primary outcomes:
measure: Average daily amount of urine phosphorus change from baseline
timeFrame: Day 5 to Day 8 after start of each dosing
Secondary outcomes:
measure: Safety profile assessed by the incidence of adverse events, vital signs, clinical laboratory tests, and 12-lead ECG
timeFrame: Up to Day 17 on Period 2
Other outcomes:
Locations:
city: Kagoshima
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References: