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Drug Interaction Study of Isavuconazole and Methadone

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pharmacokinetics of Isavuconazole; Pharmacokinetics of Methadone; Healthy Volunteers

Intervention: Isavuconazole (Drug); Methadone (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Astellas Pharma Global Development, Inc.

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Astellas Pharma Global Development


The primary purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics (PK) of methadone after single dose administration. The secondary purpose is to assess the safety and tolerability of isavuconazole alone and in combination with methadone.

Clinical Details

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 Methadone in Healthy Adult Subjects

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: Composite of pharmacokinetics (PK) of plasma for R-methadone and S-methadone: AUClast, AUCinf, and Cmax

Secondary outcome:

Composite of pharmacokinetics (PK) of plasma for R-methadone and S-methadone : tmax,t1/2, Vz/F, and CL/F

PK of plasma isavuconazole: trough concentration (Ctrough)

Composite of PK of plasma isavuconazole: AUC during the time interval between consecutive dosing (AUCtau), Cmax, and tmax

Safety assessed by recording of adverse events, laboratory evaluations, electrocardiograms (ECGs) and vital signs


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.


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 (AST) and alanine 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 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 methadone 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

Locations and Contacts

Parexel International, LLC, Glendale, California 91206, United States
Additional Information

Starting date: April 2012
Last updated: June 28, 2012

Page last updated: August 23, 2015

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