NCT02175407

A Study to Assess the Interaction Between ASP1707 and Itraconazole in Healthy Female Subjects

A Phase 1, One Sequence, Cross-over Pharmacokinetic Study to Assess the Interaction Between ASP1707 and Itraconazole, a CYP3A and P-gp Inhibitor in Healthy Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Astellas Pharma Europe B.V. · Industry
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study to explore the effect of multiple oral doses of itraconazole on the pharmacokinetics of a single oral dose of ASP1707 in healthy female subjects. This study will also evaluate the safety and tolerability of a single oral dose of ASP1707 alone and in combination with itraconazole.

Detailed description

Subjects will be confined in the clinical unit for up to 15 days.

Conditions

• Pharmacokinetics
• DDI (Drug-Drug Interaction)
• Healthy Subjects

Interventions

Type	Name	Description
DRUG	ASP1707	oral
DRUG	itraconazole	oral

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2014-06-26
• Last updated: 2014-07-03

Locations

1 site across 1 country: Germany