A Study to Explore the Effect of Food Before a Single Dose of Sitravatinib

Study Overview
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Brief Summary
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An Open-label, Randomized, Three-period, Crossover Study of the Effect of Food on the Pharmacokinetics of a Single Oral Dose of Sitravatinib in Healthy Adult Subjects

Official Title
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An Open-label, Randomized, Three-period, Crossover Study of the Effect of Food on the Pharmacokinetics of a Single Oral Dose of Sitravatinib in Healthy Adult Subjects

Conditions
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Healthy Adults

Intervention / Treatment
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* 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 Females of childbearing potential will not be pregnant or lactating and must have a negative result on an approved pregnancy test at screening and check-in. Females of childbearing potential must agree to use contraception Male subjects must agree to use contraception Able to comprehend and willing to sign an ICF and to abide by the study restrictions Key Exclusion Criteria: History of drug/chemical abuse within 2 years prior to screening. History of alcohol abuse within 12 months prior to screening Positive urine drug screen at screening or check-in or positive alcohol test at check-in. Use of tobacco- or nicotine-containing products or e-cigarettes (with or without nicotine) within 3 months prior to check-in for Period 1; or positive cotinine at screening or check-in. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days prior to study drug administration on Day 1 of Period 1. Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to study drug administration on Day 1 of Period 1. Use or intend to use any prescription medications/products within 14 days prior to study drug administration on Day 1 of Period 1.

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

Sexes Eligible for Study
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All

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
Interventional Model Description: Three Period Crossover
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fasted dosing followed by fed dosing (high-fat meal) followed by fed dosing (low-fat meal)<br>Dosing in the fasted state followed by fed dosing after high and low fat meals | Drug: sitravatinib<br>* 100 mg sitravatinib on Day 1 of each of 3 periods<br>|
| Experimental: Fasted dosing followed by fed dosing (low-fat meal) followed by fed dosing (high-fat meal)<br>Dosing in the fasted state followed by fed dosing after low and high fat meals | Drug: sitravatinib<br>* 100 mg sitravatinib on Day 1 of each of 3 periods<br>|
| Experimental: Fed dosing (high-fat meal) followed by fasted dosing followed by fed dosing (low-fat meal)<br>Dosing after a high-fat meal followed by doing in the fasted sate followed by dosing after a low-fat meal | Drug: sitravatinib<br>* 100 mg sitravatinib on Day 1 of each of 3 periods<br>|
| Experimental: Fed dosing (high-fat) followed by fed dosing (low-fat) followed by dosing in the fasted state<br>Fed dosing (high-fate meal) followed by fed dosing (low-fate meal) followed by dosing in the fasted state | Drug: sitravatinib<br>* 100 mg sitravatinib on Day 1 of each of 3 periods<br>|
| Experimental: Fed dosing (low-fat) followed dosing in the fasted state followed by fed dosing (high fat)<br>Fed dosing (low-fat) meal followed dosing in the fasted state followed by fed dosing (high-fat meal) | Drug: sitravatinib<br>* 100 mg sitravatinib on Day 1 of each of 3 periods<br>|
| Experimental: Fed dosing (low-fat) followed by fed dosing (high-fat) followed by dosing in the fasted state<br>Fed dosing after a low-fat and high-fate meals followed by dosing in the fasted state | Drug: sitravatinib<br>* 100 mg sitravatinib on Day 1 of each of 3 periods<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics - Cmax (sitravatinib) | Maximum observed plasma concentration | Up to 72 hours after dosing | 
| Pharmacokinetics - AUC∞ (sitravatinib) | Area under the plasma concentration-time curve from time zero extrapolated to infinity | Up to 72 hours after dosing | 
| Pharmacokinetics - AUClast (sitravatinib) | AUC from time zero to the last measured time point | Up to 72 hours after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events (AEs) | Incidence and severity of adverse events (AEs) dosed in the fasted and fed states in healthy adult subjects | Up to 44 days |