NCT01287858

Study to Assess Safety, Tolerability, and Pharmacokinetics of Oral Doses for AC430 in Healthy Subjects

A Phase 1, Randomized, Double Blind, Placebo Controlled, Sequential, Ascending Single-Dose and Multiple-Dose First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AC430 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

AC430 will be administered, orally under fasting conditions (fasting 4 hours before and 2 hours after dosing) with approximately 240 mL of water either once daily or twice daily. It is designed to assess the safety, tolerability, and pharmacokinetics of single and multiple oral doses of AC430.

Detailed description

A dose-finding study of AC430 in healthy volunteers.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	AC430	Healthy volunteers will either receive AC430 or placebo.

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2011-02-02
• Last updated: 2015-11-02

Locations

1 site across 1 country: United States