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

NCT ID: NCT02632331

Last Updated: 2015-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-02-28

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.

Detailed Description

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Conditions

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Healthy Volunteers

Keywords

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Food effect Pharmacokinetics ASP8825 XP13512

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fasted dosing preceding group

Group Type EXPERIMENTAL

ASP8825

Intervention Type DRUG

Oral

Fed dosing preceding group

Group Type EXPERIMENTAL

ASP8825

Intervention Type DRUG

Oral

Interventions

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ASP8825

Oral

Intervention Type DRUG

Other Intervention Names

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gabapentin enacarbil

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

44 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

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Fukuoka, , Japan

Site Status

Countries

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Japan

Other Identifiers

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8825-CL-0014

Identifier Type: -

Identifier Source: org_study_id