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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: ASP1517; Drug: Placebo

• Registration Number: NCT00978198
• Lead Sponsor: Astellas Pharma Inc

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.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-15
• Study First Submitted QC: 2009-09-15
• Study First Posted: 2009-09-16
• Status Verified: 2010-06
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Last Update Submitted: 2010-06-16
• Last Update Posted: 2010-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part 1	ASP1517	single administration
Part 1	Placebo	single administration
Part 2	ASP1517	multiple administration
Part 2	Placebo	multiple administration

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of ASP1517	During 2 weeks

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of ASP1517	During 2 weeks