Clinical trial NCT02175407: A Study to Assess the Interaction Between ASP1707 and Itraconazole in Healthy Female Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
DDI (Drug-Drug Interaction)
Healthy Subjects
Keywords: Healthy subjects
ASP1707
Itraconazole
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2014-06-26
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Pharmacokinetic parameter of ASP1707 (=R-enantiomer), AS1948006 and the sum of ASP1707 and AS1948006 with itraconazole: AUCinf
timeFrame: Day 1-15
measure: Pharmacokinetic parameter of ASP1707 (=R-enantiomer), AS1948006 and the sum of ASP1707 and AS1948006 without itraconazole: AUCinf
timeFrame: Day 1-15
measure: Pharmacokinetic parameter of ASP1707 (=R-enantiomer), AS1948006 and the sum of ASP1707 and AS1948006 with itraconazole: Cmax
timeFrame: Day 1-15
measure: Pharmacokinetic parameter of ASP1707 (=R-enantiomer), AS1948006 and the sum of ASP1707 and AS1948006 without itraconazole: Cmax
timeFrame: Day 1-15
Secondary outcomes:
measure: 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
timeFrame: Day 1-15
measure: 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
timeFrame: Day 1-15
measure: 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
timeFrame: Days 4-15
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: PAREXEL International GmbH
Study officials:
affiliation: Astellas Pharma Global Development, Inc.
name: Global Medical Lead
role: STUDY_DIRECTOR
References: