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

NCT ID: NCT01657890

Last Updated: 2015-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-01-31

Brief Summary

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

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.

Conditions

Pharmacokinetics of Isavuconazole; Healthy Volunteers; Safety and Tolerability in Elderly

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Arm 1: Isavuconazole in healthy non-elderly male subjects

age 18 to 45 years

Group Type: EXPERIMENTAL

isavuconazole

Intervention Type: DRUG

oral

Arm 2: Isavuconazole in healthy non-elderly female subjects

age 18 to 45 years

Group Type: EXPERIMENTAL

isavuconazole

Intervention Type: DRUG

oral

Arm 3: Isavuconazole in healthy elderly male subjects

age 65 years and older

Group Type: EXPERIMENTAL

isavuconazole

Intervention Type: DRUG

oral

Arm 4: Isavuconazole in healthy elderly female subjects

age 65 years and older

Group Type: EXPERIMENTAL

isavuconazole

Intervention Type: DRUG

oral

Interventions

isavuconazole

oral

Intervention Type: DRUG

Other Intervention Names

BAL8557

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Basilea Pharmaceutica International Ltd

INDUSTRY

Sponsor Role: collaborator

Astellas Pharma Global Development, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Global Development

Locations

Parexel International

Glendale, California, United States

Countries

United States

References

Desai AV, Han D, Kowalski DL, Lademacher C, Pearlman H, Yamazaki T. No Dose Adjustment for Isavuconazole Based on Age or Sex. Antimicrob Agents Chemother. 2019 May 24;63(6):e02629-18. doi: 10.1128/AAC.02629-18. Print 2019 Jun.

Reference Type: DERIVED

PMID: 30962330 (View on PubMed)

Other Identifiers

9766-CL-0041

Identifier Type: -

Identifier Source: org_study_id