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

Phase 1

Completed

• Conditions: Pharmacokinetics; Healthy Subjects; DDI (Drug-Drug Interaction)
• Interventions: Drug: ASP1707; Drug: itraconazole

• Registration Number: NCT02175407
• Lead Sponsor: Astellas Pharma Europe B.V.

Brief 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.

Study Timeline

• Study Start: 2014-04
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Study First Submitted: 2014-06-24
• Study First Submitted QC: 2014-06-24
• Study First Posted: 2014-06-26
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-01
• Last Update Posted: 2014-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 14

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ASP1707 alone	ASP1707	-
ASP1707 + itraconazole	itraconazole	-
ASP1707 + itraconazole	ASP1707	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameter of ASP1707 (=R-enantiomer), AS1948006 and the sum of ASP1707 and AS1948006 without itraconazole: AUCinf	Day 1-15
Pharmacokinetic parameter of ASP1707 (=R-enantiomer), AS1948006 and the sum of ASP1707 and AS1948006 with itraconazole: AUCinf	Day 1-15	Area under the plasma concentration - time curve from time zero to infinity (AUCinf)
Pharmacokinetic parameter of ASP1707 (=R-enantiomer), AS1948006 and the sum of ASP1707 and AS1948006 with itraconazole: Cmax	Day 1-15	Maximum concentration (Cmax)
Pharmacokinetic parameter of ASP1707 (=R-enantiomer), AS1948006 and the sum of ASP1707 and AS1948006 without itraconazole: Cmax	Day 1-15

Secondary Outcome Measures

Name	Time	Method
Composite of pharmacokinetics of ASP1707 (=R-enantiomer), AS1948006 and the sum of ASP1707 and AS1948006 concentration with itraconazole: AUClast, tmax, t1/2, AUCinf (%extrap), tlag, MRT, λz, CL/F, Vz/F, TER and MPR	Day 1-15	Area under the plasma concentration - time curve from time zero to time of last measurable concentration (AUClast), Time to attain Cmax (tmax), apparent terminal elimination half life (t1/2), area under the concentration-time curve from the time of dosing extrapolated to time infinity (AUCinf \[%extrap\]), absorption lag time (tlag), Mean Residence Time (MRT), terminal elimination rate constant (λz), apparent total systemic clearance (CL/F) (ASP1707 (=R-enantiomer) only), apparent volume of distribution during terminal elimination phase (Vz/F) (ASP1707 only), total exposure ratio (TER) and metabolite-parent ratio (MPR) (AS1948006 only)
Composite of pharmacokinetics of ASP1707 (=R-enantiomer), AS1948006 and the sum of ASP1707 and AS1948006 concentration without itraconazole: AUClast, tmax, t1/2, AUCinf (%extrap), tlag, MRT, λz, CL/F, Vz/F, TER and MPR	Day 1-15	CL/F (ASP1707 (=R-enantiomer) only), Vz/F (ASP1707 only), MPR (AS1948006 only)
Composite of pharmacokinetics of itraconazole and hydroxy itraconazole concentrations with ASP1707 (=R-enantiomer), AS1948006 and the sum of ASP1707 and AS1948006: AUCtau, tmax, Cmax, MPR (hydroxy itraconazole only), Ctrough	Days 4-15	Area under the plasma concentration - time curve between consecutive dosing (AUCtau), plasma concentration at the end of a dosing interval at steady state (Ctrough)

Trial Locations

Locations (1)

PAREXEL International GmbH; 🇩🇪 Berlin, Germany