Healthy, Pharmacokinetics of ASP0456
Conditions
Keywords
ASP0456, Pharmacokinetics, safety, tolerability
Brief summary
A study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending dose of ASP0456 in non-elderly healthy subjects.
Interventions
DRUGASP0456
oral
DRUGPlacebo
oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 44 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy, as judged by the investigator/subinvestigator based on the results of physical examination and all tests obtained * Body weight (at screening); ≥50.0 kg,\<80.0 kg * BMI(at screening): ≥17.6,\<26.4
Exclusion criteria
* Received any investigational drugs in other clinical or post-marketing studies within 120 days before the study * Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the study * Received medication within 10 days before dose is administered or is scheduled to receive medication * History of drug allergies * Upper (e.g. nausea, vomiting, stomachache) and lower (e.g. abdominal pain) gastrointestinal disease within 7 days before the study * Concurrent or previous hepatic disease * Concurrent or previous heart disease * Concurrent or previous renal disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of ASP0456 assessed by its plasma concentration change | For 48 hours after dosing |
Secondary
| Measure | Time frame |
|---|---|
| Safety assessed by the incidence of adverse events, vital signs, 12-lead ECGs and labo tests | For 48 hours after dosing |
Countries
Japan
Outcome results
None listed