Drug Interaction Study of Isavuconazole and Methadone

NCT01582425 | Completed Phase 1

• 1 other identifier: 9766-CL-0027
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacokinetics of Isavuconazole; Pharmacokinetics of Methadone; Healthy Volunteers

Keywords

isavuconazole; methadone; Healthy Volunteers; BAL8557

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

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

  Days 1 and 20

• PK of plasma isavuconazole: trough concentration (Ctrough)

  Days 18 and Days 21 through 29

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

  Days 19 and 20

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

  Up to Day 36

Study Arms (1)

Isavuconazole and methadone

EXPERIMENTAL

Single dose of methadone on Days 1 and 20, isavuconazole 3 times a day (TID) on Days 16-17 as a loading dose, isavuconazole once a day (QD) on Days 18-28

Drug: Isavuconazole; Drug: Methadone

Interventions

Isavuconazole DRUG

oral

Also known as: BAL8557, BAL4815

Isavuconazole and methadone

Methadone DRUG

oral

Also known as: Dolopine

Isavuconazole and methadone

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Parexel International, LLC

Glendale, California, 91206, United States

Location

MeSH Terms

Interventions

isavuconazole; Methadone

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals

Study Officials

• Medical Director

  Astellas Pharma Global Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2012
• First Posted: April 20, 2012
• Study Start: April 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 2, 2012

Record last verified: 2012-06

Locations

US (1)