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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: ASP8825

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 44 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fasted dosing preceding group	Drug: ASP8825; Oral; Other Names: gabapentin enacarbil
Experimental: Fed dosing preceding group	Drug: ASP8825; Oral; Other Names: gabapentin enacarbil

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: December 14, 2015
• First Submitted That Met QC Criteria: December 14, 2015
• First Posted (Estimate): December 16, 2015

Study Record Updates

• Last Update Posted (Estimate): December 16, 2015
• Last Update Submitted That Met QC Criteria: December 14, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Food effect; ASP8825; XP13512
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin
• Other Study ID Numbers: 8825-CL-0014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED