Study to Evaluate the Safety and Pharmacokinetics of ASP2151 in Healthy Non-elderly and Elderly Subjects

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2006-10-31

Brief Summary

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The objective of this study is to evaluate the safety and the pharmacokinetics of ASP2151 after multiple oral dosing of ASP2151 in healthy non-elderly male and elderly male Japanese subjects, and to compare the pharmacokinetics of ASP2151 in healthy non-elderly male and elderly male Japanese subjects.

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Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ASP2151 Low dose in non-elderly subjects group

Subjects will receive ASP2151 daily on Days 1 to 7.

Group Type EXPERIMENTAL

ASP2151

Intervention Type DRUG

Oral

ASP2151 High dose in non-elderly subjects group

Subjects will receive ASP2151 daily on Days 1 to 7.

Group Type EXPERIMENTAL

ASP2151

Intervention Type DRUG

Oral

ASP2151 Low dose in elderly subjects group

Subjects will receive ASP2151 daily on Days 1 to 7.

Group Type EXPERIMENTAL

ASP2151

Intervention Type DRUG

Oral

ASP2151 High dose in elderly subjects group

Subjects will receive ASP2151 daily on Days 1 to 7.

Group Type EXPERIMENTAL

ASP2151

Intervention Type DRUG

Oral

Placebo in non-elderly subjects group

Subjects will receive matching placebo daily on Days 1 to 7.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral

Placebo in elderly subjects group

Subjects will receive matching placebo daily on Days 1 to 7.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral

Interventions

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ASP2151

Oral

Intervention Type DRUG

Placebo

Oral

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Body weight: ≥50.0 kg and \<85.0 kg
* Body mass index (BMI): ≥17.6 and \<26.4 kg/m2

Exclusion Criteria

* Subjects with a complication of any diseases
* Subjects with a history of hepatic disease
* Subjects with a history of heart disease
* Subjects with a history of respiratory disease
* Subjects with a history of alimentary disease
* Subjects with a history of renal disease
* Subjects with a history of cerebrovascular disorder
* Subjects with a history of malignant tumor
* Subjects with a history of drug allergies or allergies disorders excluding pollinosis
* Subjects with a history of drug dependency or alcohol dependence syndrome
* Subjects who developed genital herpes or herpes zoster within 90 days before the initial dosing
* Subjects who do not meet any of the criteria for laboratory tests
* Subjects who received medications within 14 days before the initial dosing.
* Subjects who received any investigational drugs in other clinical trials or post-marketing studies within 120 days before screening or the initial dosing
* Excessive alcohol drinking or smoking habit
* Subjects who previously received administration of ASP2151 (including placebo)
* Abnormalities detected on an ophthalmological examination
* Subjects who deviate from the normal range of standard 12-lead ECG at screening

Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes