Fukuoka, Japan
NCT Number: NCT02632331
ASP8825 - A Study to Investigate the Food Effect on the Pharmacokinetics of ASP8825
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.
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Notify MeKey information
Conditions
Age range
20 year–44 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
ASP8825
DrugOral
Other names: gabapentin enacarbil
Primary outcomes
-
Pharmacokinetics (PK) parameter of gabapentin: Cmax
Time frame: 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
Time frame: 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
Time frame: Up to 8 days after the final study drug dosing
AEs: Adverse Events
-
Safety assessed by Vital signs
Time frame: 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
Time frame: Up to 3 days after the each study drug dosing
Hematology, blood biochemistry, and urinalysis
-
Safety assessed by 12-lead ECGs
Time frame: Up to 3 days after the each study drug dosing
ECG: Electrocardiogram
Secondary outcomes
-
PK parameters of gabapentin tmax
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Sponsors and collaborators
Lead sponsor
Astellas Pharma Inc
Industry
Registry information
Official study title
Pharmacokinetic (PK) Study of ASP8825 - Evaluation of the Effect of Food on the Pharmacokinetics
Important dates
- Study start
- 2009
- Primary completion
- 2009
- Study completion
- 2009
- First posted
- Dec 16, 2015
- Registry last updated
- Dec 16, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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