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

Astellas

Status and phase

Completed

Phase 1

Conditions

DDI (Drug-Drug Interaction)

Healthy Subjects

Pharmacokinetics

Treatments

Drug: ASP1707

Drug: itraconazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT02175407

1707-CL-0030

2013-005370-21 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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

Enrollment

14 patients

Sex

Female

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Female subject must be either of non child bearing potential, post-menopausal prior to screening, or documented surgically sterile. Or, if of childbearing potential, must agree not to try to become pregnant during the study and for 28 days after the final study drug administration, must have a negative urine pregnancy test at Day -1 and, if heterosexually active, agree to consistently use two forms of highly effective form of birth control starting at screening and throughout the study period and for 28 days after the final study drug administration.
Female subject must not be breastfeeding at screening or during the study period, and for 28 days after the final study drug administration.
Female subject must not donate ova starting at screening and throughout the study period, and for 28 days after the final study drug administration.

Exclusion criteria

Female subject who has been pregnant within 6 months prior to screening assessment or breast feeding within 3 months prior to screening.
Subject uses grapefruit (more than 3x 200 mL) or marmalade (more than three times) in the week prior to admission to the Clinical Unit until ESV, as reported by the subject.
Subject is a vulnerable subject (e.g., subject kept in detention).