Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT01884558
Eligibility Criteria:
Inclusion Criteria:
* The subject has a body weight of at least 45 kg and a body mass index of 18 to 32 kg/m2, inclusive.
* QTcF must be 360 to 430 msec for males and 370 to 450 msec for females
* Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and serum creatinine must not be above the normal range.
* Female subject is of non-childbearing potential or if of childbearing potential must use highly effective birth control from Screening through 28 days after the end of the study. Females must not be breastfeeding or donate ova from Screening through 20 days after the end of the study.
* Male subject must be using highly effective contraception from Screening through 90 days after final study drug administration. Male subject must not donate sperm starting at Screening through 90 days after final study drug administration.
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 either Short or 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 B surface antigen, hepatitis C antibodies at Screening or is known to be positive for human immunodeficiency virus.
* The subject has a known or suspected allergy to any of the components of the trial products 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) in the last 6 months.
* The subject has had treatment with any prescribed or non-prescribed drugs in the 2 weeks prior to Day 1, with the exception of occasional use of acetaminophen up to 2 g/day.
* The subject has participated in any interventional clinical study or has received any investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to Screening.
* The subject has participated in a prior study with isavuconazole.
* The subject has history of consuming more than 14 units of alcoholic beverages per week within 6 months prior to screening or has a history of alcoholism or drug/chemical/substance abuse within past 2 years prior to screening or the subject tests positive at screening or Day -1 for alcohol or drugs of abuse.
* The subject is an employee of the Astellas Group or vendors involved in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01884558
Study Brief:
Protocol Section:
NCT01884558