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

ASP1517 Phase 1 Clinical Study - Single and Multiple Oral Dosing of ASP1517 in Healthy Non-elderly Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00978198

Enrollment

100

Registered

2009-09-16

Start date

2009-09-30

Completion date

2010-06-30

Last updated

2010-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Pharmacokinetics, Safety and tolerability, Plasma concentration, ASP1517, FG-4592

Brief summary

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.

Detailed description

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

Interventions

DRUGASP1517

oral

DRUGPlacebo

oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

20 Years to 44 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of ASP1517	During 2 weeks

Secondary

Measure	Time frame
Pharmacokinetics of ASP1517	During 2 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026