NCT01225224

Single and Multiple Oral Administration Study of ASP015K in Healthy Nonelderly Volunteers

Phase I Study of ASP015K: Single-Dose and Multiple-Dose Oral Administration in Healthy Nonelderly Men

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: Male
• Age: 20 Years – 44 Years
• Healthy volunteers: Accepted

Summary

A study to evaluate the safety, tolerability and PK profiles of single and multiple doses of ASP015K in healthy nonelderly men.

Detailed description

This study consists of two parts; single and multiple administration parts. In single administration part, multiple dose levels of ASP015K or placebo are administered to Japanese and Caucasian men to evaluate whether there is ethnic differences in the pharmacokinetics and pharmacodynamics of ASK015K. In multiple administration part, drugs are administered only to Japanese volunteers.

Conditions

• Pharmacokinetics of ASP015K
• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	peficitinib	oral
DRUG	Placebo	oral

Timeline

• Start date: 2009-11-18
• Primary completion: 2010-03-10
• Completion: 2010-03-10
• First posted: 2010-10-20
• Last updated: 2024-10-16

Locations

1 site across 1 country: Japan