A Study to Explore the Effect of Food Before a Single Dose of Sitravatinib
- Registration Number
- NCT04800614
- Lead Sponsor
- Mirati Therapeutics Inc.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Fasted dosing followed by fed dosing (high-fat meal) followed by fed dosing (low-fat meal) sitravatinib Dosing in the fasted state followed by fed dosing after high and low fat meals Fasted dosing followed by fed dosing (low-fat meal) followed by fed dosing (high-fat meal) sitravatinib Dosing in the fasted state followed by fed dosing after low and high fat meals Fed dosing (high-fat meal) followed by fasted dosing followed by fed dosing (low-fat meal) sitravatinib Dosing after a high-fat meal followed by doing in the fasted sate followed by dosing after a low-fat meal Fed dosing (high-fat) followed by fed dosing (low-fat) followed by dosing in the fasted state sitravatinib Fed dosing (high-fate meal) followed by fed dosing (low-fate meal) followed by dosing in the fasted state Fed dosing (low-fat) followed dosing in the fasted state followed by fed dosing (high fat) sitravatinib Fed dosing (low-fat) meal followed dosing in the fasted state followed by fed dosing (high-fat meal) Fed dosing (low-fat) followed by fed dosing (high-fat) followed by dosing in the fasted state sitravatinib Fed dosing after a low-fat and high-fate meals followed by dosing in the fasted state
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
Covance Clinical Research Unit, Inc.
🇺🇸Dallas, Texas, United States