Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Mirati Therapeutics Inc.
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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
You may not be if
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.
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