Clinical trial NCT01582425: Drug Interaction Study of Isavuconazole and Methadone
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics of Isavuconazole
Pharmacokinetics of Methadone
Healthy Volunteers
Keywords: isavuconazole
methadone
Healthy Volunteers
BAL8557
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Basilea Pharmaceutica International Ltd
First posted: 2012-04-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Composite of pharmacokinetics (PK) of plasma for R-methadone and S-methadone: AUClast, AUCinf, and Cmax
timeFrame: Days 1 and 20
Secondary outcomes:
measure: Composite of pharmacokinetics (PK) of plasma for R-methadone and S-methadone : tmax,t1/2, Vz/F, and CL/F
timeFrame: Days 1 and 20
measure: PK of plasma isavuconazole: trough concentration (Ctrough)
timeFrame: Days 18 and Days 21 through 29
measure: Composite of PK of plasma isavuconazole: AUC during the time interval between consecutive dosing (AUCtau), Cmax, and tmax
timeFrame: Days 19 and 20
measure: Safety assessed by recording of adverse events, laboratory evaluations, electrocardiograms (ECGs) and vital signs
timeFrame: Up to Day 36
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Parexel International, LLC
state: California
Study officials:
affiliation: Astellas Pharma Global Development
name: Medical Director
role: STUDY_DIRECTOR
References: