Healthy Adults
Conditions
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
Interventions
DRUGsitravatinib
100 mg sitravatinib on Day 1 of each of 3 periods
Sponsors
Mirati Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Three Period Crossover
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed