The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of Repaglinide and possible metabolites after single dose administration. In addition, this study will assess the effect of multiple doses of isavuconazole on the pharmacokinetics of caffeine and possible metabolites after single dose administration. Safety and tolerability of isavuconazole alone and in combination with Repaglinide or in combination with caffeine will be assessed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
oral
oral
oral
Parexel Early Phase Clinical Unit
Baltimore, Maryland, United States
Pharmacokinetics of plasma repaglinide and possible metabolite concentration: Area under the concentration-time curve from time of dosing to the last quantifiable concentration (AUClast)
Time frame: Days 1 and 14
Pharmacokinetics of plasma repaglinide and possible metabolite concentration: Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf)
Time frame: Days 1 and 14
Pharmacokinetics of plasma repaglinide and possible metabolite concentration: Maximum concentration (Cmax)
Time frame: Days 1 and 14
Pharmacokinetics of caffeine and possible metabolite concentration: Area under the concentration-time curve from time of dosing to the last quantifiable concentration (AUClast)
Time frame: Days 3 and 16
Pharmacokinetics of caffeine and possible metabolite concentration: Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf)
Time frame: Days 3 and 16
Pharmacokinetics of caffeine and possible metabolite concentration: Maximum concentration (Cmax)
Time frame: Days 3 and 16
Pharmacokinetics of plasma isavuconazole concentration: Trough concentration (Ctrough)
Time frame: Days 10-18
Pharmacokinetics of plasma isavuconazole concentration: Area under the concentration-time curve during the time interval between consecutive dosing (AUCtau)
Time frame: Days 13, 14 and 16
Pharmacokinetics of plasma isavuconazole concentration: Maximum concentration (Cmax)
Time frame: Days 13, 14 and 16
Pharmacokinetics of plasma isavuconazole concentration: Time after dosing when Cmax occurs (tmax)
Time frame: Days 13, 14 and 16
Safety assessed through adverse events
Time frame: up to Day 24
Safety assessed through clinical laboratory evaluations
Laboratory assessments will include hematology, serum chemistry and urinalysis parameters
Time frame: up to Day 18
Safety assessed by 12-lead electrocardiograms (ECGs)
Time frame: up to Day 18
Safety assessed through vital signs
Vital signs will be measured including oral temperature, pulse, and sitting blood pressure
Time frame: up to Day 18
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