Kagoshima, Japan
NCT Number: NCT02531204
A Study of ASP1585 to Evaluate the 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.
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Conditions
Age range
20 year–44 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
ASP1585
Drugoral
Other names: Bixalomer, Kiklin
Primary outcomes
-
Average daily amount of urine phosphorus change from baseline
Time frame: 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 outcomes
-
Safety profile assessed by the incidence of adverse events, vital signs, clinical laboratory tests, and 12-lead ECG
Time frame: Up to Day 17 on Period 2
ECG: Electrocardiogram
Sponsors and collaborators
Lead sponsor
Astellas Pharma Inc
Industry
Registry information
Official study title
Pharmacodynamic Study of ASP1585 - Verification of Bioequivalence Between ASP1585 Granules and ASP1585 Capsules
Important dates
- Study start
- 2014
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Aug 24, 2015
- Registry last updated
- Aug 24, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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