A Study to Explore the Effect of Food Before a Single Dose of Sitravatinib
NCT ID: NCT04800614
Last Updated: 2022-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2021-03-15
2022-03-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Fasted dosing followed by fed dosing (high-fat meal) followed by fed dosing (low-fat meal)
Dosing in the fasted state followed by fed dosing after high and low fat meals
sitravatinib
100 mg sitravatinib on Day 1 of each of 3 periods
Fasted dosing followed by fed dosing (low-fat meal) followed by fed dosing (high-fat meal)
Dosing in the fasted state followed by fed dosing after low and high fat meals
sitravatinib
100 mg sitravatinib on Day 1 of each of 3 periods
Fed dosing (high-fat meal) followed by fasted dosing followed by fed dosing (low-fat meal)
Dosing after a high-fat meal followed by doing in the fasted sate followed by dosing after a low-fat meal
sitravatinib
100 mg sitravatinib on Day 1 of each of 3 periods
Fed dosing (high-fat) followed by fed dosing (low-fat) followed by dosing in the fasted state
Fed dosing (high-fate meal) followed by fed dosing (low-fate meal) followed by dosing in the fasted state
sitravatinib
100 mg sitravatinib on Day 1 of each of 3 periods
Fed dosing (low-fat) followed dosing in the fasted state followed by fed dosing (high fat)
Fed dosing (low-fat) meal followed dosing in the fasted state followed by fed dosing (high-fat meal)
sitravatinib
100 mg sitravatinib on Day 1 of each of 3 periods
Fed dosing (low-fat) followed by fed dosing (high-fat) followed by dosing in the fasted state
Fed dosing after a low-fat and high-fate meals followed by dosing in the fasted state
sitravatinib
100 mg sitravatinib on Day 1 of each of 3 periods
Interventions
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sitravatinib
100 mg sitravatinib on Day 1 of each of 3 periods
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
55 Years
ALL
Yes
Sponsors
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Mirati Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Curtis Chin, MD
Role: STUDY_DIRECTOR
Mirati Therapeutics
Locations
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Covance Clinical Research Unit, Inc.
Dallas, Texas, United States
Countries
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Other Identifiers
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516-009
Identifier Type: -
Identifier Source: org_study_id
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