A Study to Explore the Effect of Food Before a Single Dose of Sitravatinib

Mirati Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy Adults

Treatments: Drug: sitravatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04800614

516-009

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

36 participants in 6 patient groups

Fasted dosing followed by fed dosing (high-fat meal) followed by fed dosing (low-fat meal)

Experimental group

Description:

Dosing in the fasted state followed by fed dosing after high and low fat meals

Treatment:

Drug: sitravatinib

Fasted dosing followed by fed dosing (low-fat meal) followed by fed dosing (high-fat meal)

Experimental group

Description:

Dosing in the fasted state followed by fed dosing after low and high fat meals

Treatment:

Drug: sitravatinib

Fed dosing (high-fat meal) followed by fasted dosing followed by fed dosing (low-fat meal)

Experimental group

Description:

Dosing after a high-fat meal followed by doing in the fasted sate followed by dosing after a low-fat meal

Treatment:

Drug: sitravatinib

Fed dosing (high-fat) followed by fed dosing (low-fat) followed by dosing in the fasted state

Experimental group

Description:

Fed dosing (high-fate meal) followed by fed dosing (low-fate meal) followed by dosing in the fasted state

Treatment:

Drug: sitravatinib

Fed dosing (low-fat) followed dosing in the fasted state followed by fed dosing (high fat)

Experimental group

Description:

Fed dosing (low-fat) meal followed dosing in the fasted state followed by fed dosing (high-fat meal)

Treatment:

Drug: sitravatinib

Fed dosing (low-fat) followed by fed dosing (high-fat) followed by dosing in the fasted state

Experimental group

Description:

Fed dosing after a low-fat and high-fate meals followed by dosing in the fasted state

Treatment:

Drug: sitravatinib