ASP8825 - A Study to Investigate the Food Effect on the Pharmacokinetics of ASP8825

Astellas

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: ASP8825

Study type

Interventional

Funder types

Industry

Identifiers

NCT02632331

8825-CL-0014

Details and patient eligibility

About

The objective of this study is to evaluate the effect of food on the pharmacokinetics and safety after administration of ASP8825 in healthy non-elderly adult male subjects.

Enrollment

18 patients

Sex

All

Ages

20 to 44 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Body weight: ≥50.0 kg and <80.0 kg
Body mass index BMI: ≥17.6 and <26.4 [BMI= Body weight (kg)/(Height (m))2]

Exclusion criteria

Subjects who received any study drugs in other clinical trials or post-marketing studies within 120 days before screening
Subjects who received or are scheduled to receive medications (including over-the-counter [OTC] drugs) within seven days before the hospital admission day of period 1.
Subjects who deviate from the normal range of blood pressure, pulse rate, body temperature and standard 12-lead ECG at screening or the hospital admission day of period 1
Subjects who meet any of the criteria for laboratory tests at screening or the hospital admission day of period 1. Normal ranges of each test specified at the study site or the test/assay organization will be used as the normal ranges in this study.
Subjects with a complication of drug allergies
Subjects who developed upper gastrointestinal symptoms (e.g., nausea, vomiting, and stomachache) within seven days before the hospital admission day of period 1
Subjects with a complication or history of hepatic disease (hepatitis viral and drug-induced liver injury, etc.)
Subjects with a complication or history of heart disease (cardiac failure congestive, angina pectoris and arrhythmia requiring treatments, etc.)
Subjects with a complication or history of respiratory disease (severe asthma bronchial and bronchitis chronic, etc.) (except for a history of non-severe infantile asthma)
Subjects with a complication or history of alimentary disease (severe peptic ulcer, reflux esophagitis, etc.) (except for a history of appendicitis)
Subjects with a complication or history of renal disease (acute kidney injury, glomerulonephritis, nephritis interstitial, etc.) (except for a history of calculus)
Subjects with a complication or history of cerebrovascular disorder (cerebral infarction, etc.)
Subjects with a complication or history of malignant tumor
Subjects who have a habit of excessive alcohol drinking or smoking
Subjects who previously received administration of ASP8825