The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of a single dose of methotrexate. Safety and tolerability of isavuconazole will be assessed alone and in combination with methotrexate.
Subjects will check-in to the clinic on Day -1 and remain confined through completion of the study procedures on Day 10. A follow-up telephone call will be made on Day 16 to check on health status.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
24
oral
oral
California Clinical Trials Medical Group
Glendale, California, United States
Pharmacokinetics (PK) of methotrexate in plasma: Area Under the Concentration-Time Curve (AUC) from the time of dosing to the last quantifiable concentration (AUClast)
Time frame: Days 1 and 8 (15 plasma samples obtained from time zero to 36 hours post dose)
PK of methotrexate in plasma: AUC from the time of dosing to infinity (AUCinf)
Time frame: Days 1 and 8 (15 plasma samples obtained from time zero to 36 hours post dose)
PK of methotrexate in plasma: Maximum Concentration (Cmax)
Time frame: Days 1 and 8 (15 plasma samples obtained from time zero to 36 hours post dose)
PK variable for isavuconazole in plasma: Trough Concentration (Ctrough)
Time frame: Days 6, 9 and 10 (1 sample prior to isavuconazole dosing)
Composite of PK variables for isavuconazole in plasma: AUCtau, Cmax and tmax
AUC during the time interval between consecutive dosing (AUCtau); the time after dosing when Cmax occurs (tmax)
Time frame: Days 7 and 8 (13 samples collected per day)
Composite of PK variables for methotrexate in plasma: t1/2, tmax, CL/F and Vz/F
Apparent Terminal Elimination Half-life (t1/2); Apparent Body Clearance After Oral Dosing (CL/F); Apparent Volume of Distribution (Vz/F)
Time frame: Days 1 and 8 (15 plasma samples obtained from time zero to 36 hours post dose)
Composite of PK variables for 7- hydroxymethotrexate in plasma: AUClast, AUCinf, t1/2, Cmax and tmax
Time frame: Days 1 and 8 (15 plasma samples obtained from time zero to 36 hours post dose)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.