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

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

Administered orally as a free base capsule

Sitravatinib

Administered orally as a malate salt capsule

Study Director

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.

Relative Bioavailability of Two Different Capsule Formulations of Sitravatinib in Healthy Adults

A Phase 1, Open-label, Single-dose, Randomized Crossover Study to Evaluate the Relative Bioavailability of Two Different Capsule Formulations of Sitravatinib in Healthy Subjects

Adverse events (AEs) and serious adverse events are defined as an AE that starts during or after the first dose, or starts prior to the first dose and increases in severity after the first dose, including vital signs, physical examination, electrocardiogram, and laboratory parameters

BeiGene

Safety Analysis Set included participants who received at least 1 dose of sitravatinib

Sitravatinib malate salt capsule 100 mg on Day 1 in Periods 1 and 2, with a minimum washout period between dose administrations of 14 days

Sitravatinib Malate Salt Capsule

Sitravatinib free base capsule 120 mg (reference) on Day 1 in Periods 1 and 2, with a minimum washout period between dose administrations of 14 days

Sitravatinib Free Base Capsule

Sitravatinib free base capsule 120 mg on Day 1 of Period 1 then sitravatinib malate salt capsule 100 mg on Day 1 of Period 2, with a minimum washout period between dose administrations of 14 days

Dosing Sequence 1: Sitravatinib Free Base Capsule Then Malate Salt Capsule

Sitravatinib malate salt capsule 100 mg on Day 1 of Period 1 then sitravatinib free base capsule 120 mg on Day 1 of Period 2, with a minimum washout period between dose administrations of 14 days

Dosing Sequence 2: Sitravatinib Malate Salt Capsule Then Free Base Capsule

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Sitravatinib Malate Salt Capsule (Test) vs. Sitravatinib Free Base Capsule (Reference). Analysis based on Relative Bioavailability Analysis Set, defined as the subset of participants in the PK Parameters Analysis Set who had at least 1 primary PK parameter (AUC0-t, AUC0-inf and Cmax of sitravatinib) in both periods.

Sitravatinib malate salt capsule 100 mg (test) on Day 1 of Periods 1 and 2, with a minimum washout period between dose administrations of 14 days

Sitravatinib free base capsule 120 mg (reference) on Day 1 of Periods 1 and 2, with a minimum washout period between dose administrations of 14 days

Pharmacokinetic (PK) parameters analysis set included all participants who received at least 1 dose of sitravatinib and had at least 1 PK parameter of sitravatinib

Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-∞) of Sitravatinib

Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC0-t) of Sitravatinib

Maximum Observed Plasma Concentration (Cmax) of Sitravatinib

Time of the Maximum Observed Plasma Concentration (Tmax) of Sitravatinib

Apparent Terminal Elimination Half-life (T1/2) of Sitravatinib

Apparent Total Plasma Clearance (CL/F) of Sitravatinib

Apparent Volume of Distribution (Vz/F) of Sitravatinib

At least 1 treatment-emergent adverse event (TEAE)

Grade 3 or 4 TEAEs

Serious adverse events

TEAE leading to permanent discontinuation of study treatment

TEAE leading to death

Sitravatinib malate salt capsule 100 mg on Day 1 of Periods 1 and 2, with a minimum washout period between dose administrations of 14 days

Sitravatinib free base capsule 120 mg on Day 1 of Periods 1 and 2, with a minimum washout period between dose administrations of 14 days

Spots Global Cancer Trial Database for Relative Bioavailability of Two Different Capsule Formulations of Sitravatinib in Healthy Adults

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