Safety, Tolerability and Pharmacokinetic Study of ASP1517 in Healthy Non-elderly Male Volunteers

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-06-30

Brief Summary

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The purpose of the study is to evaluate the safety and tolerability of ASP1517 after single or multiple oral administration in healthy non-elderly adult male subjects.

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Detailed Description

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The study consists of two parts, single and multiple dose. Within each part participants will be randomized to either ASP1517 or placebo.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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Part 1

single administration

Group Type EXPERIMENTAL

ASP1517

Intervention Type DRUG

oral

Placebo

Intervention Type DRUG

oral

Part 2

multiple administration

Group Type EXPERIMENTAL

ASP1517

Intervention Type DRUG

oral

Placebo

Intervention Type DRUG

oral

Interventions

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ASP1517

oral

Intervention Type DRUG

Placebo

oral

Intervention Type DRUG

Other Intervention Names

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FG-4592

Eligibility Criteria

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Inclusion Criteria

* Body weight: ≥50.0 kg, \<80.0 kg
* BMI: ≥18.5 kg/m2, \<25.0 kg/m2
* Eligible, as judged by the investigator/subinvestigator based on the results of physical examinations (subjective symptoms and objective findings) and all tests obtained at screening and up to the timing immediately before study medication
* Supine blood pressure: Systolic blood pressure ≥90 mmHg, ≤130 mmHg; Diastolic blood pressure ≤85 mmHg
* Pulse rate at rest in supine position: ≥40 bpm, \<100 bpm

Exclusion Criteria

* Received any investigational drugs in other clinical or post-marketing studies within 120 days before the screening assessment
* Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the screening assessment
* Received medication within 7 days before hospital admission or is scheduled to receive medication
* History of drug allergies
* Upper gastrointestinal disease (e.g. nausea, vomiting, stomachache) within 7 days before the study
* Excessive smoking or drinking habit (measure of "excessive": alcohol: 45 g/day, smoking: 20 cigarettes/day)

Minimum Eligible Age

20 Years

Maximum Eligible Age

44 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes