ASP8825 - A Study to Investigate the Food Effect on the Pharmacokinetics of ASP8825
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Drug: ASP8825
- Registration Number
- NCT02632331
- Lead Sponsor
- Astellas Pharma Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Fasted dosing preceding group ASP8825 - Fed dosing preceding group ASP8825 -
- Primary Outcome Measures
Name Time Method 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
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
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 Outcome Measures
Name Time Method 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 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
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 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: 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: 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