NCT01364974

A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP015K

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Sequential Group, Multiple-Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASP015K in Healthy, Non-Elderly Male and Female Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to explore safety and tolerability of multiple oral doses of ASP015K in healthy volunteers.

Detailed description

Subjects will be confined to the clinical research unit for 19 days. Subjects will receive a follow-up phone call to asses safety 1 to 5 days after being discharged from the study. Subjects will receive study drug twice per day (BID) on days 1 to 13 of the 14 day treatment period, and will receive a single dose of study drug on the morning of day 14 of the treatment period.

Conditions

• Healthy Subjects
• Pharmacokinetics of ASP015K
• Pharmacodynamics

Interventions

Type	Name	Description
DRUG	ASP015K	oral
DRUG	Placebo	oral

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2011-06-03
• Last updated: 2011-06-03

Locations

1 site across 1 country: United States