A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Prednisone in Healthy Adult Subjects

Sponsor
Astellas Pharma Global Development, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01711827
Collaborator
Basilea Pharmaceutica International Ltd (Industry)
21
1
1
29
22

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of prednisolone after single dose administration of prednisone. This study will also assess the safety and tolerability of isavuconazole alone and in combination with prednisone.

Study Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
A Phase 1, Open-label, Sequential Study of the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Prednisone in Healthy Adult Subjects
Study Start Date :
Feb 1, 2012
Actual Primary Completion Date :
Mar 1, 2012
Actual Study Completion Date :
Mar 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Isavuconazole and Prednisone

Single dose of prednisone on Days 1 and 9, isavuconazole 3 times a day (TID) on Days 5-6, isavuconazole once a day (QD) on Days 7-10

Drug: Isavuconazole
oral
Other Names:
  • BAL8557
  • Drug: Prednisone
    oral

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics of plasma prednisolone: AUClast, [Predose on Days 1 and 9 and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 (Days 2 and 10), and 48 (Days 3 and 11) hours postdose]

      Area under the concentration-time curve (AUC) from the time of dosing to the last quantifiable concentration (AUC last)

    2. Pharmacokinetics of plasma prednisolone: AUCinf [Predose on Days 1 and 9 and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 (Days 2 and 10), and 48 (Days 3 and 11) hours postdose]

      AUC from the time of dosing to infinity (AUCinf),

    3. Pharmacokinetics of plasma prednisolone: Cmax [Predose on Days 1 and 9 and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 (Days 2 and 10), and 48 (Days 3 and 11) hours postdose]

      Maximum concentration (Cmax)

    Secondary Outcome Measures

    1. Pharmacokinetics of plasma isavuconazole concentration: Trough concentration (Ctrough) [Day 7 predose; Day10 predose and Day 11 postdose]

    2. Composite of pharmacokinetics of plasma isavuconazole concentration: AUCtau, Cmax, and tmax [Day 8 predose and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 16 hours postdose; Day 9 predose and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours postdose]

      AUC during the time interval between consecutive dosing (AUCtau), Cmax, and time to attain Cmax (tmax)

    3. Composite of pharmacokinetics of plasma prednisone: AUClast, AUCinf, Cmax, tmax, t1/2, Vz/F, and CL/F [Predose on Days 1 and 9 and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 (Days 2 and 10), and 48 (Days 3 and 11) hours postdose]

      Apparent terminal elimination half life ( t1/2), apparent volume of distribution (Vz/F), and apparent body clearance after oral dosing (CL/F)

    4. Composite of pharmacokinetics of plasma prednisolone: t max and t1/2 [Predose on Days 1 and 9 and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 (Days 2 and 10), and 48 (Days 3 and 11) hours postdose]

    5. Safety assessed by recording of adverse events, laboratory evaluations, electrocardiograms (ECGs) and vital signs [18 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • The subject has a body weight of at least 45 kg and has a body mass index (BMI) of 18 to 32 kg/m2, inclusive

    • Results for aspartate aminotransferase (ALT) must be ≤ upper limit of normal and total bilirubin must be ≤ 1.5 mg/dL

    • The female subject agrees to sexual abstinence, or is surgically sterile, postmenopausal (defined as at least 2 years at Screening without menses), or using a medically acceptable double barrier method (e.g. spermicide and diaphragm, or spermicide and condom) to prevent pregnancy and agrees to continue using this method from Screening until 3 weeks after the follow-up visit at the end of the study; and is not lactating or pregnant as documented by negative pregnancy tests at Screening and Day -1

    • The male subject agrees to sexual abstinence, is surgically sterile, or is using a medically acceptable method to prevent pregnancy and agrees to continue using this method from Screening until 3 weeks after the follow-up visit at the end of the study

    Exclusion Criteria:
    • The subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia or torsade de pointes, structural heart disease, or family history of Long QT syndrome (suggested by sudden death or a close relative at a young age due to possible or probably cardiac causes

    • The subject has a history of tuberculosis or exposure to anyone known or suspected to have tuberculosis or any illness that might confound the results of the study or pose additional risk in administering study drug to the subject

    • The subject has a positive result for hepatitis C antibodies, hepatitis B surface antigen, or QuantiFERON®-TB Gold test at Screening or is known to be positive for human immunodeficiency virus (HIV)

    • The subject has a known or suspected allergy to any of the components of the trial products including prednisone or the azole class of compounds, or a history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reactions

    • The subject is a smoker (any use of tobacco or nicotine containing products) within 6 months prior to Screening

    • The subject has had treatment with prescription drugs or complementary and alternative medicines within 14 days prior to Day -1, or over-the-counter medications within 1 week prior to Day -1, with the exception of acetaminophen up to 2 g/day

    • The subject has a recent history (within the last 2 years) of drug or alcohol abuse or a positive drug and/or alcohol screen

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Parexel International, LLC Glendale California United States 91206

    Sponsors and Collaborators

    • Astellas Pharma Global Development, Inc.
    • Basilea Pharmaceutica International Ltd

    Investigators

    • Study Director: Medical Director, Astellas Pharma Global Development

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Astellas Pharma Global Development, Inc.
    ClinicalTrials.gov Identifier:
    NCT01711827
    Other Study ID Numbers:
    • 9766-CL-0024
    First Posted:
    Oct 22, 2012
    Last Update Posted:
    Oct 22, 2012
    Last Verified:
    Oct 1, 2012
    Keywords provided by Astellas Pharma Global Development, Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 22, 2012