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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Tumor

Intervention / Treatment
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* Drug: Sitravatinib
* Drug: Sitravatinib


Participation Criteria
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Eligibility Criteria
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Key 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 Key Exclusion Criteria: History of stomach or intestinal surgery or resection Have previously completed or withdrawn from this study or any other study investigating sitravatinib and have previously received the investigational product.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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dosing Sequence 1: Sitravatinib Free Base then Malate Salt<br>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 | Drug: Sitravatinib<br>* Administered orally as a free base capsule<br>Drug: Sitravatinib<br>* Administered orally as a malate salt capsule<br>|
| Experimental: Dosing Sequence 2: Sitravatinib Malate Salt then Free Base<br>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 | Drug: Sitravatinib<br>* Administered orally as a free base capsule<br>Drug: Sitravatinib<br>* Administered orally as a malate salt capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 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 | 
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events | 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 | Up to Week 8 |