Drug Interaction Study of Isavuconazole and Methadone

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01582425
• Other study ID #: 9766-CL-0027
• Status: Completed
• Phase: Phase 1
• First received: April 19, 2012
• Last updated: June 28, 2012
• Start date: April 2012
• Est. completion date: June 2012

Study information

• Verified date: June 2012
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Healthy Volunteers
• Pharmacokinetics of Isavuconazole
• Pharmacokinetics of Methadone

Intervention

Drug:
• Isavuconazole
oral
• Methadone
oral

Locations

Country	Name	City	State
United States	Parexel International, LLC	Glendale	California

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Global Development, Inc.	Basilea Pharmaceutica International Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of pharmacokinetics (PK) of plasma for R-methadone and S-methadone: AUClast, AUCinf, and Cmax	Area under the curve (AUC) from time of dosing to last quantifiable concentration (AUClast ), AUC from time 0 extrapolated to infinity (AUCinf), maximum concentration (Cmax)	Days 1 and 20	No
Secondary	Composite of pharmacokinetics (PK) of plasma for R-methadone and S-methadone : tmax,t1/2, Vz/F, and CL/F	Time to attain Cmax (tmax) , apparent terminal elimination half-life (t1/2), apparent volume of distribution (Vz /F), and apparent body clearance after oral dosing (CL/F)	Days 1 and 20	No
Secondary	PK of plasma isavuconazole: trough concentration (Ctrough)		Days 18 and Days 21 through 29	No
Secondary	Composite of PK of plasma isavuconazole: AUC during the time interval between consecutive dosing (AUCtau), Cmax, and tmax		Days 19 and 20	No
Secondary	Safety assessed by recording of adverse events, laboratory evaluations, electrocardiograms (ECGs) and vital signs		Up to Day 36	Yes