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

Phase 1

Completed

• Conditions: Healthy Adults
• Interventions: Drug: sitravatinib

• Registration Number: NCT04800614
• Lead Sponsor: Mirati Therapeutics Inc.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-11
• Study First Submitted QC: 2021-03-12
• Study Start: 2021-03-15
• Study First Posted: 2021-03-16
• Primary Completion: 2021-07-06
• Study Completion: 2022-03-28
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-04
• Last Update Posted: 2022-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fasted dosing followed by fed dosing (high-fat meal) followed by fed dosing (low-fat meal)	sitravatinib	Dosing in the fasted state followed by fed dosing after high and low fat meals
Fasted dosing followed by fed dosing (low-fat meal) followed by fed dosing (high-fat meal)	sitravatinib	Dosing in the fasted state followed by fed dosing after low and high fat meals
Fed dosing (high-fat meal) followed by fasted dosing followed by fed dosing (low-fat meal)	sitravatinib	Dosing after a high-fat meal followed by doing in the fasted sate followed by dosing after a low-fat meal
Fed dosing (high-fat) followed by fed dosing (low-fat) followed by dosing in the fasted state	sitravatinib	Fed dosing (high-fate meal) followed by fed dosing (low-fate meal) followed by dosing in the fasted state
Fed dosing (low-fat) followed dosing in the fasted state followed by fed dosing (high fat)	sitravatinib	Fed dosing (low-fat) meal followed dosing in the fasted state followed by fed dosing (high-fat meal)
Fed dosing (low-fat) followed by fed dosing (high-fat) followed by dosing in the fasted state	sitravatinib	Fed dosing after a low-fat and high-fate meals followed by dosing in the fasted state

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Covance Clinical Research Unit, Inc.; 🇺🇸 Dallas, Texas, United States