A Study to Explore the Effect of Food Before a Single Dose of Sitravatinib
Study Details
Study Description
Brief Summary
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
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 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 |
Drug: sitravatinib
100 mg sitravatinib on Day 1 of each of 3 periods
|
Experimental: 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 |
Drug: sitravatinib
100 mg sitravatinib on Day 1 of each of 3 periods
|
Experimental: 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 |
Drug: sitravatinib
100 mg sitravatinib on Day 1 of each of 3 periods
|
Experimental: 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 |
Drug: sitravatinib
100 mg sitravatinib on Day 1 of each of 3 periods
|
Experimental: 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) |
Drug: sitravatinib
100 mg sitravatinib on Day 1 of each of 3 periods
|
Experimental: 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 |
Drug: sitravatinib
100 mg sitravatinib on Day 1 of each of 3 periods
|
Outcome Measures
Primary Outcome Measures
- Pharmacokinetics - Cmax (sitravatinib) [Up to 72 hours after dosing]
Maximum observed plasma concentration
- Pharmacokinetics - AUC∞ (sitravatinib) [Up to 72 hours after dosing]
Area under the plasma concentration-time curve from time zero extrapolated to infinity
- Pharmacokinetics - AUClast (sitravatinib) [Up to 72 hours after dosing]
AUC from time zero to the last measured time point
Secondary Outcome Measures
- Adverse Events (AEs) [Up to 44 days]
Incidence and severity of adverse events (AEs) dosed in the fasted and fed states in healthy adult subjects
Eligibility Criteria
Criteria
Key Inclusion Criteria:
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Body mass index between 18.0 and 32.0 kg/m2, inclusive.
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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
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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
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Male subjects must agree to use contraception
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Able to comprehend and willing to sign an ICF and to abide by the study restrictions
Key Exclusion Criteria:
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History of drug/chemical abuse within 2 years prior to screening.
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History of alcohol abuse within 12 months prior to screening
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Positive urine drug screen at screening or check-in or positive alcohol test at check-in.
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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.
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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.
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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.
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Use or intend to use any prescription medications/products within 14 days prior to study drug administration on Day 1 of Period 1.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Covance Clinical Research Unit, Inc. | Dallas | Texas | United States | 75247 |
Sponsors and Collaborators
- Mirati Therapeutics Inc.
Investigators
- Study Director: Curtis Chin, MD, Mirati Therapeutics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 516-009