Study of the Pharmacokinetics of Isavuconazole in Healthy Non-Elderly and Elderly Male and Female Subjects

Overview

The purpose of this study is to evaluate the pharmacokinetics of isavuconazole in healthy non-elderly and elderly male and female subjects.

Full Title of Study: “A Phase 1, Open Label, Parallel Group, Single Dose Study to Evaluate the Pharmacokinetics of Isavuconazole in Healthy Non-Elderly and Elderly Male and Female Subjects”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2013

Detailed Description

All subjects receive a single dose of isavuconazole on Day 1 under fasting conditions. Subjects are confined to study center from Day -1 until Day 4 when they are discharged. Subjects return for outpatient visits on Days 6, 8, 11, 13 and 15.

Interventions

  • Drug: isavuconazole
    • oral

Arms, Groups and Cohorts

  • Experimental: Arm 1: Isavuconazole in healthy non-elderly male subjects
    • age 18 to 45 years
  • Experimental: Arm 2: Isavuconazole in healthy non-elderly female subjects
    • age 18 to 45 years
  • Experimental: Arm 3: Isavuconazole in healthy elderly male subjects
    • age 65 years and older
  • Experimental: Arm 4: Isavuconazole in healthy elderly female subjects
    • age 65 years and older

Clinical Trial Outcome Measures

Primary Measures

  • Pharmacokinetics (PK) variables for isavuconazole (in plasma): AUCinf, AUClast, and Cmax
    • Time Frame: Day 1: Pre-dose, 0.5, 1, 1.5, 2, 3, 4 ,6, 8,10, 12, 16, 20, 24, 36, 48, 72, 120, 168, 240, 288, 336 hours post-dose on Day 1
    • Area under the concentration-time curve from time of dosing to infinity (AUCinf), Area under the concentration-time curve from time of dosing to the last quantifiable concentration (AUClast) and Maximum concentration (Cmax)

Secondary Measures

  • PK variables for isavuconazole (in plasma): Vz/F, CL/F, t1/2, tmax
    • Time Frame: Day 1: Pre-dose, 0.5, 1,1.5, 2, 3, 4, 6, 8,10, 12, 16, 20, 24 ,36, 48, 72, 120, 168, 240, 288, 336 hours post-dose on Day 1
    • Apparent volume of distribution (Vz/F), Apparent body clearance after oral dosing (CL/F), Apparent terminal elimination half-life (t ½), Time to attain maximum concentration (tmax)
  • Safety assessed by recording adverse events, laboratory assessments, physical examinations, vital signs, electrocardiograms (ECGs)
    • Time Frame: Day 1-15

Participating in This Clinical Trial

Inclusion Criteria

  • Subjects are healthy, non-elderly males and females between 18 and 45 years and healthy, elderly males and females 65 years of age and older
  • 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
  • The estimated (calculated) creatinine clearance must be within the age-appropriate normal range, if abnormal, the abnormality is not clinically significant, as determined by the Investigator
  • Results for aspartate aminotransferase (AST) and alanine aminotransferase (ALT), and total bilirubin must be within the normal range
  • 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 agree 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 of a close relative at a young age due to possible or probable cardiac causes)
  • The subject has a positive result for hepatitis C antibodies, hepatitis B surface antigen 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 the azole class of compounds, or a history of multiple and/or severe allergies to drugs or foods (as judged by the investigator), 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, if non-elderly, 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, if elderly, has not been on stable concomitant medications (minor necessary dosing changes are acceptable) for at least 4 weeks prior to study drug administration or is taking any medication that would interfere with the evaluation of isavuconazole in this study (CYP3A4 inducer or inhibitor)
  • The subject has a recent history (within the last 2 years) of drug or alcohol abuse, as defined by the investigator, or a positive drug and/or alcohol screen

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Astellas Pharma Global Development, Inc.
  • Collaborator
    • Basilea Pharmaceutica International Ltd
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Director, Study Director, Astellas Pharma Global Development

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