NCT01998646

A Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP4058 Following Single Oral Doses

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacoknetics of ASP4058 Following Single Oral Doses in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 130 (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 explore the safety, tolerability and pharmacokinetics (PK) of single ascending oral doses of ASP4058 in non-elderly, healthy male and female subjects. This study will also explore the effect of food on the PK of ASP4058.The food-effect crossover group was open-label treatment with no placebo control.

Detailed description

Subjects will remain in the clinic for 9 days. Subjects will return to the clinic for follow-up on days 12 and 30 to collect additional safety information.

Conditions

• Pharmacokinetics of ASP4058
• Healthy Subjects
• Food Effect of ASP4058

Interventions

Type	Name	Description
DRUG	ASP4058	Oral tablet
DRUG	Placebo	Oral tablet

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2013-12-02
• Last updated: 2013-12-02

Locations

2 sites across 1 country: United States