Status:
COMPLETED
A Study to Explore the Effect of Food Before a Single Dose of Sitravatinib
Lead Sponsor:
Mirati Therapeutics Inc.
Conditions:
Healthy Adults
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
March 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2022
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04800614
Start Date
March 15 2021
End Date
March 28 2022
Last Update
April 6 2022
Active Locations (1)
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1
Covance Clinical Research Unit, Inc.
Dallas, Texas, United States, 75247