Healthy Volunteers
Conditions
Keywords
Food effect, Pharmacokinetics, ASP8825, XP13512
Brief summary
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.
Interventions
DRUGASP8825
Oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 44 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK) parameter of gabapentin: Cmax | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing | Cmax: Maximum concentration |
| PK parameters of gabapentin: AUClast | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing | AUClast: Area under the concentration-time curve from the time of dosing extrapolated to the last measurable concentration |
| Safety assessed by AEs | Up to 8 days after the final study drug dosing | AEs: Adverse Events |
| Safety assessed by Vital signs | Up to 3 days after the each study drug dosing | Supine blood pressure, supine pulse rate and axillary body temperature |
| Safety assessed by Laboratory tests | Up to 3 days after the each study drug dosing | Hematology, blood biochemistry, and urinalysis |
| Safety assessed by 12-lead ECGs | Up to 3 days after the each study drug dosing | ECG: Electrocardiogram |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK parameters of gabapentin: CL/F | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing | CL/F: Apparent total systemic clearance |
| PK parameters of gabapentin: kel | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing | kel: Terminal elimination rate constant |
| PK parameters of gabapentin tmax | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing | tmax: Time of Cmax |
| PK parameter of gabapentin: AUCinf | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing | AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity |
| PK parameters of gabapentin: t1/2 | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing | t1/2: Terminal elimination half-life |
| PK parameters of gabapentin: MRTinf | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing | MRTinf: Mean residence time from the time of dosing extrapolated to time infinity |
| PK parameters of gabapentin: MRTlast | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing | MRTlast: Mean residence time from the time of dosing extrapolated to the last measurable concentration |
Countries
Japan
Outcome results
None listed