Clinical trial NCT02632331: ASP8825 - A Study to Investigate the Food Effect on the Pharmacokinetics of ASP8825
Official title: Pharmacokinetic (PK) Study of ASP8825 - Evaluation of the Effect of Food on the Pharmacokinetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Food effect
Pharmacokinetics
ASP8825
XP13512
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2015-12-16
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pharmacokinetics (PK) parameter of gabapentin: Cmax
timeFrame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing
measure: PK parameters of gabapentin: AUClast
timeFrame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing
measure: Safety assessed by AEs
timeFrame: Up to 8 days after the final study drug dosing
measure: Safety assessed by Vital signs
timeFrame: Up to 3 days after the each study drug dosing
measure: Safety assessed by Laboratory tests
timeFrame: Up to 3 days after the each study drug dosing
measure: Safety assessed by 12-lead ECGs
timeFrame: Up to 3 days after the each study drug dosing
Secondary outcomes:
measure: PK parameters of gabapentin tmax
timeFrame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing
measure: PK parameter of gabapentin: AUCinf
timeFrame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing
measure: PK parameters of gabapentin: t1/2
timeFrame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing
measure: PK parameters of gabapentin: CL/F
timeFrame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing
measure: PK parameters of gabapentin: MRTinf
timeFrame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing
measure: PK parameters of gabapentin: MRTlast
timeFrame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing
measure: PK parameters of gabapentin: kel
timeFrame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing
Other outcomes:
Locations:
city: Fukuoka
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References: