Clincosm LogoSign in Get a demo

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

Sponsor
Astellas Pharma Europe B.V. (Industry)
Overall Status
Completed
CT.gov ID
NCT02175407
Collaborator
(none)
14
Enrollment
1
Location
2
Arms
2
Duration (Months)
7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
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 Start Date :
Apr 1, 2014
Actual Primary Completion Date :
Jun 1, 2014
Actual Study Completion Date :
Jun 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: ASP1707 alone

Drug: ASP1707
oral
Experimental: ASP1707 + itraconazole

Drug: ASP1707
oral

Drug: itraconazole
oral

Outcome Measures

Primary Outcome Measures

  1. 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)

  2. Pharmacokinetic parameter of ASP1707 (=R-enantiomer), AS1948006 and the sum of ASP1707 and AS1948006 without itraconazole: AUCinf [Day 1-15]

  3. Pharmacokinetic parameter of ASP1707 (=R-enantiomer), AS1948006 and the sum of ASP1707 and AS1948006 with itraconazole: Cmax [Day 1-15]

    Maximum concentration (Cmax)

  4. Pharmacokinetic parameter of ASP1707 (=R-enantiomer), AS1948006 and the sum of ASP1707 and AS1948006 without itraconazole: Cmax [Day 1-15]

Secondary Outcome Measures

  1. 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)

  2. 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)

  3. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 PAREXEL International GmbH Berlin Germany 14050

Sponsors and Collaborators

  • Astellas Pharma Europe B.V.

Investigators

  • Study Director: Global Medical Lead, Astellas Pharma Global Development, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Astellas Pharma Europe B.V.
ClinicalTrials.gov Identifier:
NCT02175407
Other Study ID Numbers:
  • 1707-CL-0030
  • 2013-005370-21
First Posted:
Jun 26, 2014
Last Update Posted:
Jul 3, 2014
Last Verified:
Jul 1, 2014
Keywords provided by Astellas Pharma Europe B.V.
Healthy subjects
ASP1707
Itraconazole
Additional relevant MeSH terms:
Itraconazole

Study Results

No Results Posted as of Jul 3, 2014