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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02531204
• Other study ID #: 1585-CL-0201
• Status: Completed
• Phase: Phase 1
• First received: August 12, 2015
• Last updated: August 20, 2015
• Start date: August 2014
• Est. completion date: February 2015

Study information

• Verified date: August 2015
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 44 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy
• Urine Phosphorus Excretion

Intervention

Drug:
• ASP1585
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Safety profile assessed by the incidence of adverse events, vital signs, clinical laboratory tests, and 12-lead ECG	ECG: Electrocardiogram	Up to Day 17 on Period 2	No