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

Astellas

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Placebo

Drug: ASP1517

Study type

Interventional

Funder types

Industry

Identifiers

NCT00978198

1517-CL-0201

Details and patient eligibility

About

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.

Full description

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

Enrollment

100 patients

Sex

Male

Ages

20 to 44 years old

Volunteers

Accepts Healthy Volunteers

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)