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
Overview
- Phase
- Phase 1
- Intervention
- sitravatinib
- Conditions
- Healthy Adults
- Sponsor
- Mirati Therapeutics Inc.
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Pharmacokinetics - Cmax (sitravatinib)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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
Investigators
Eligibility Criteria
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
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
- •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
- •Use or intend to use any prescription medications/products within 14 days prior to study drug administration on Day 1 of Period 1.
Arms & Interventions
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
Intervention: sitravatinib
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
Intervention: sitravatinib
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
Intervention: sitravatinib
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
Intervention: sitravatinib
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)
Intervention: sitravatinib
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
Intervention: sitravatinib
Outcomes
Primary Outcomes
Pharmacokinetics - Cmax (sitravatinib)
Time Frame: Up to 72 hours after dosing
Maximum observed plasma concentration
Pharmacokinetics - AUC∞ (sitravatinib)
Time Frame: Up to 72 hours after dosing
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Pharmacokinetics - AUClast (sitravatinib)
Time Frame: Up to 72 hours after dosing
AUC from time zero to the last measured time point
Secondary Outcomes
- Adverse Events (AEs)(Up to 44 days)