NCT02141425

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

A Phase 1, Randomized, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP015K Following Single Doses in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of single ascending doses of ASP015K.

Detailed description

Subjects will be enrolled in 1 of 3 dose cohorts (low, medium and high). Each cohort will consist of 8 subjects with a 3:1 randomization ratio for ASP015K to placebo. Subjects will be confined to the clinic for study procedures until day 4 (5 days). After all subjects in a dose cohort have completed study procedures through day 4, a decision will be made whether or not dosing and enrollment of the next dose cohort should occur, which will only take place after a review of the safety and tolerability data through day 4 of the most recent dose cohort and any additional reported adverse events (AEs) for previously dosed cohorts.

Conditions

• Healthy Volunteers
• Pharmacokinetics of ASP015K

Interventions

Type	Name	Description
DRUG	ASP015K	oral
DRUG	Placebo	oral

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2014-05-19
• Last updated: 2014-06-04

Locations

1 site across 1 country: United States