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

Study Overview
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Brief Summary
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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.

Official Title
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Pharmacokinetic (PK) Study of ASP8825 - Evaluation of the Effect of Food on the Pharmacokinetics

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: ASP8825


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fasted dosing preceding group<br> | Drug: ASP8825<br>* Oral<br>* Other names: gabapentin enacarbil;|
| Experimental: Fed dosing preceding group<br> | Drug: ASP8825<br>* Oral<br>* Other names: gabapentin enacarbil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK) parameter of gabapentin: Cmax | Cmax: Maximum concentration | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing | 
| PK parameters of gabapentin: AUClast | AUClast: Area under the concentration-time curve from the time of dosing extrapolated to the last measurable concentration | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing | 
| Safety assessed by AEs | AEs: Adverse Events | Up to 8 days after the final study drug dosing | 
| Safety assessed by Vital signs | Supine blood pressure, supine pulse rate and axillary body temperature | Up to 3 days after the each study drug dosing | 
| Safety assessed by Laboratory tests | Hematology, blood biochemistry, and urinalysis | Up to 3 days after the each study drug dosing | 
| Safety assessed by 12-lead ECGs | ECG: Electrocardiogram | Up to 3 days after the each study drug dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameters of gabapentin tmax | tmax: Time of Cmax | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing | 
| PK parameter of gabapentin: AUCinf | AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing | 
| PK parameters of gabapentin: t1/2 | t1/2: Terminal elimination half-life | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing | 
| PK parameters of gabapentin: CL/F | CL/F: Apparent total systemic clearance | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing | 
| PK parameters of gabapentin: MRTinf | MRTinf: Mean residence time from the time of dosing extrapolated to time infinity | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing | 
| PK parameters of gabapentin: MRTlast | MRTlast: Mean residence time from the time of dosing extrapolated to the last measurable concentration | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing | 
| PK parameters of gabapentin: kel | kel: Terminal elimination rate constant | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food effect, Pharmacokinetics, ASP8825, XP13512