A Phase 1 Open-label, Two-cohort, One-sequence Crossover Study to Investigate the Effect of P glycoprotein Inhibitor (Itraconazole) and Inducer (Rifampin) on the Pharmacokinetics, Safety, and Tolerability of Sitravatinib in Healthy Subjects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
36
50 mg Sitravatinib on Day 1 (Group 1A)
100 mg Sitravatinib on Day 1 (Group 2A)
Itraconazole QD from Day 9 to Day 18, and Sitravatinib 50 mg at Day 12 (Group 1B)
Labcorp Drug Development Clinical Research Unit
Dallas, Texas, United States
Pharmacokinetics - Cmax (sitravatinib)
Maximum observed plasma concentration
Time frame: Up to Day 168 hours after dosing
Pharmacokinetics - AUC∞ (sitravatinib)
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Time frame: Up to 168 hours after dosing
Pharmacokinetics - AUClast (sitravatinib)
Area under the curve from time zero to the last measured time point
Time frame: Up to 168 hours after dosing
Pharmacokinetics - tmax (sitravatinib)
Terminal elimination half-life
Time frame: Up to 168 hours after dosing
Pharmacokinetics - CL/F (sitravatinib)
Apparent total plasma clearance when dosed orally
Time frame: Up to 168 hours after dosing
Pharmacokinetics - Vz/F (sitravatinib)
Apparent volume of distribution when dosed orally
Time frame: Up to 168 hours after dosing
Pharmacokinetics - uf (sitravatinib)
Unbound fraction
Time frame: Up to 168 hours after dosing
Adverse Events (AEs)
Incidence and severity of AEs
Time frame: Up to 12 weeks from screening
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Rifampin QD from Day 9 to Day 22, and Sitravatinib 100 mg at Day 16 (Group 2B)