Clinical trial: Drug Interaction Study of Multiple Doses of Isavuconazole and Single Dose of Atorvastatin (NCT01635946)

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

          -  The subject's clinical laboratory test results at Screening and Day 1 are within
             normal limits unless the Investigator considers the abnormality to be "not clinically
             significant." Results for aspartate aminotransferase (AST), alanine aminotransferase
             (ALT), and total bilirubin must not be above the normal range

          -  Subject agrees to sexual abstinence, or is surgically sterile, or is using a medically
             acceptable double barrier method to prevent pregnancy during the study and for three
             weeks after the follow up phone call at the end of the study, or, if female, is
             postmenopausal

        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/had a symptomatic, viral, bacterial (including upper respiratory
             infection), or fungal (non-cutaneous) infection within 1 week prior to clinic
             admission on Day -1.

          -  The subject has received a vaccination within the last 30 days prior to study drug
             administration

          -  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 (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) in the
             last 6 months

          -  The subject has had treatment with prescription drugs or complementary and alternative
             medicines within 14 days prior to Day -1, or over-the-counter medication 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 screen at Screening or Day -1
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years

Patient description (medical language): A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear.  Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus.  Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane.  Conduction hearing loss is noted in the left ear.  The remainder of the ear, nose, and throat examination is normal.

Patient description (patient's own words): I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal.

Does the patient match the trial criteria? 0