Healthy, Pharmacokinetics of ASP1941
Conditions
Keywords
ASP1941, Food effect, Pharmacokinetics
Brief summary
This study is to investigate the effect of food on the pharmacokinetics, the pharmacodynamics and safety of ASP1941 after administration of ASP1941 in healthy non-elderly adult male subjects.
Detailed description
This will be a randomized, open-label, 3-way crossover design study to investigate the effect of food on the pharmacokinetics, the pharmacodynamics and safety of ASP1941 after administration of ASP1941 in healthy non-elderly adult male subjects. Each subject will receive a single dose of ASP1941 under fasting condition, before meal and after meal.
Interventions
DRUGASP1941
oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
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 examinations and laboratory tests * Body weight ; ≥50.0 kg, \<80.0 kg * Body Mass Index ; ≥17.6, \<26.4 * Written informed consent has been obtained
Exclusion criteria
* Received any investigational drugs within 120 days before the screening assessment * Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or d components within 14 days before the screening assessment * Received medication within 7 days before hospital admission * A deviation from the assessment criteria of physical examinations or laboratory tests at screening or upon admission * History of drug allergies * With renal, hepatic, gastrointestinal, heart, cerebrovascular or respiratory diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK) profiles of ASP1941 (in plasma): AUCinf, AUClast and Cmax | For 72 hours after each administration | Area under the curve (AUC) from time 0 extrapolated to infinity (AUCinf), AUC from time of dosing to last quantifiable concentration (AUClast ), and maximum concentration (Cmax) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK) profiles of ASP1941 (in plasma): tmax, t1/2, apparent distribution volume, apparent body clearance | For 72 hours after each administration | Time to attain Cmax (tmax) , apparent terminal elimination half-life (t1/2 ) |
| Safety assessed by incidence of adverse event, vital signs, 12-lead ECG and laboratory tests | For 72 hours after each administration | — |
| Changes in urinary glucose excretion | Before and for 72 hours after each administration | — |
Countries
Japan
Outcome results
None listed