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

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ClinicalTrials.gov Identifier: NCT02175407
Recruitment Status : Completed
First Posted : June 26, 2014
Last Update Posted : July 3, 2014
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( 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.

Condition or disease Intervention/treatment Phase
Pharmacokinetics DDI (Drug-Drug Interaction) Healthy Subjects Drug: ASP1707 Drug: itraconazole Phase 1

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

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Study Type : Interventional  (Clinical Trial)
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 : April 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: ASP1707 alone Drug: ASP1707
oral

Experimental: ASP1707 + itraconazole Drug: ASP1707
oral

Drug: itraconazole
oral




Primary Outcome Measures :
  1. Pharmacokinetic parameter of ASP1707 (=R-enantiomer), AS1948006 and the sum of ASP1707 and AS1948006 with itraconazole: AUCinf [ Time Frame: 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 [ Time Frame: Day 1-15 ]
  3. Pharmacokinetic parameter of ASP1707 (=R-enantiomer), AS1948006 and the sum of ASP1707 and AS1948006 with itraconazole: Cmax [ Time Frame: Day 1-15 ]
    Maximum concentration (Cmax)

  4. Pharmacokinetic parameter of ASP1707 (=R-enantiomer), AS1948006 and the sum of ASP1707 and AS1948006 without itraconazole: Cmax [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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)



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175407


Locations
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Germany
PAREXEL International GmbH
Berlin, Germany, 14050
Sponsors and Collaborators
Astellas Pharma Europe B.V.
Investigators
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Study Director: Global Medical Lead Astellas Pharma Global Development, Inc.

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Responsible Party: Astellas Pharma Europe B.V.
ClinicalTrials.gov Identifier: NCT02175407     History of Changes
Other Study ID Numbers: 1707-CL-0030
2013-005370-21 ( EudraCT Number )
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: July 3, 2014
Last Verified: July 2014

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Europe B.V. ):
Healthy subjects
ASP1707
Itraconazole

Additional relevant MeSH terms:
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Itraconazole
Hydroxyitraconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors