Skip to main content
OpenTrials
Completed

NCT Number: NCT00978198

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

20 year–44 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Kantou, Japan

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ASP1517

Drug

oral

Other names: FG-4592

Placebo

Drug

oral

Primary outcomes

  1. Safety and tolerability of ASP1517

    Time frame: During 2 weeks

Secondary outcomes

  1. Pharmacokinetics of ASP1517

    Time frame: During 2 weeks

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 16, 2009
Registry last updated
Jun 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.