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

NCT02531204 | Completed Phase 1

• 1 other identifier: 1585-CL-0201
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

ASP1585; Bioequivalence; Pharmacodynamic; Phosphate binder; Bixalomer; urinary phosphorus excretion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

ASP1585 granules preceding group

EXPERIMENTAL

Drug: ASP1585

ASP1585 capsules preceding group

ACTIVE COMPARATOR

Drug: ASP1585

Interventions

ASP1585 DRUG

oral

Also known as: Bixalomer, Kiklin

ASP1585 capsules preceding group; ASP1585 granules preceding group

Eligibility Criteria

• Age: 20 Years - 44 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Unknown Facility

Kagoshima, Japan

Location

MeSH Terms

Interventions

bixalomer

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2015
• First Posted: August 24, 2015
• Study Start: August 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: August 24, 2015

Record last verified: 2015-08

Locations

JP (1)