Relative Bioavailability of Two Different Capsule Formulations of Sitravatinib in Healthy Adults
- Registration Number
- NCT04472650
- Lead Sponsor
- BeiGene
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 26
Inclusion Criteria
- Body mass index between 18.0 and 32.0 kg/m2, inclusive.
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations at Screening and/or Check-in as assessed by the Investigator (or designee).
- Able to swallow multiple capsules.
Key
Exclusion Criteria
- History of stomach or intestinal surgery or resection
- Have previously completed or withdrawn from this study or any other study investigating sitravatinib and have previously received the investigational product.
- Participants who, in the opinion of the Investigator (or designee), should not participate in this study.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Dosing Sequence 2: Sitravatinib Malate Salt then Free Base Sitravatinib 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 Dosing Sequence 1: Sitravatinib Free Base then Malate Salt Sitravatinib 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
- Primary Outcome Measures
Name Time Method Apparent Total Plasma Clearance (CL/F) of Sitravatinib Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period Time of the Maximum Observed Plasma Concentration (Tmax) of Sitravatinib Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period Maximum Observed Plasma Concentration (Cmax) of Sitravatinib Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC0-t) of Sitravatinib Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-∞) of Sitravatinib Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period Apparent Terminal Elimination Half-life (T1/2) of Sitravatinib Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period Apparent Volume of Distribution (Vz/F) of Sitravatinib Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period
- Secondary Outcome Measures
Name Time Method Number of Participants With Adverse Events Up to Week 8 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
Trial Locations
- Locations (1)
Linear Clinical Research
🇦🇺Nedlands, Western Australia, Australia