Clinical trial NCT04472650
Conditions: Tumor
Sponsor: BeiGene
Start date: 2020-07-23; Completion date: 2020-11-09
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of the study was to investigate the relative bioavailability and pharmacokinetics (PK) of sitravatinib free base and malate salt capsule formulations following oral administration in healthy adults.

Detailed description:

Arms: arm 1: Sitravatinib free base capsule 120 mg on Day 1 in Period 1 then sitravatinib malate salt capsule 100 mg on Day 1 in Period 2, with a minimum washout period between dose administrations of 14 days arm 2: Sitravatinib malate salt capsule 100 mg on Day 1 in Period 1 then sitravatinib free base capsule 120 mg on Day 1 in Period 2, with a minimum washout period between dose administrations of 14 days
Interventions: intervention 1: Sitravatinib intervention 2: Sitravatinib
Intervention descriptions: intervention 1: Administered orally as a free base capsule intervention 2: Administered orally as a malate salt capsule

Protocol documents:
Prot_000.pdf: 
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VV-CLIN-032570
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