The purpose of this study is to evaluate the effects of coadministration of voriconazole or quinidine on the pharmacokinetics (PK) of repotrectinib in healthy male and female (individual not of childbearing potential \[INOCBP\]) participants.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Fortrea - Daytona Beach
Daytona Beach, Florida, United States
Maximum observed plasma concentration (Cmax)
Time frame: Up to Day 23
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time frame: Up to Day 23
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time frame: Up to Day 23
Number of participants with Adverse Events (AEs)
Time frame: Up to Day 52
Number of participants with Severe Adverse Events (SAEs)
Time frame: Up to Day 52
Number of participants with physical examination abnormalities
Time frame: Up to Day 23
Number of participants with vital sign abnormalities
Time frame: Up to Day 23
Number of participants with electrocardiogram abnormalities
Time frame: Up to Day 23
Number of participants with clinical safety laboratory test abnormalities
Time frame: Up to Day 22
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to Day 23
Apparent terminal phase half-life (T-HALF)
Time frame: Up to Day 23
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Apparent total body clearance (CLT/F)
Time frame: Up to Day 23
Apparent volume of distribution of terminal phase (Vz/F)
Time frame: Up to Day 23
Cmax
Time frame: Up to Day 23
Area under the plasma concentration-time curve over one dosing interval (AUC(TAU))
Time frame: Up to Day 23
Trough observed plasma concentration (Ctrough)
Time frame: Up to Day 23