A Phase 1 Study of the Effect of Acid-reducing Agents on the Pharmacokinetics of a Single Oral Dose of Sitravatinib in Healthy Adult Subjects. The study is a single-center, open-label, 2-period, 2-treatment, fixed-sequence crossover, parallel-group study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
15
100 mg sitravatinib on Day 1
40 mg QD on Day 1 to Day 7 of Period 2 in Group 1
40 mg PO 2 hrs after sitravatinib in Period 2 of Group 2
Covance Clinical Research Unit Inc.
Madison, Wisconsin, United States
Pharmacokinetics - Cmax (sitravatinib)
Maximum observed plasma concentration
Time frame: Up to Day 7 after dosing
Pharmacokinetics - AUC∞ (sitravatinib)
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Time frame: Up to 72 hours after dosing
Pharmacokinetics - AUClast (sitravatinib)
Area under the curve from time zero to the last measured time point
Time frame: Up to 72 hours after dosing
Adverse Events (AEs)
Incidence and severity of AEs
Time frame: Up to 9 weeks from screening
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