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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Adults
• Intervention / Treatment: Drug: sitravatinib

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75247
      • Covance Clinical Research Unit, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fasted dosing followed by fed dosing (high-fat meal) followed by fed dosing (low-fat meal); Dosing in the fasted state followed by fed dosing after high and low fat meals	Drug: sitravatinib; 100 mg sitravatinib on Day 1 of each of 3 periods
Experimental: Fasted dosing followed by fed dosing (low-fat meal) followed by fed dosing (high-fat meal); Dosing in the fasted state followed by fed dosing after low and high fat meals	Drug: sitravatinib; 100 mg sitravatinib on Day 1 of each of 3 periods
Experimental: Fed dosing (high-fat meal) followed by fasted dosing followed by fed dosing (low-fat meal); Dosing after a high-fat meal followed by doing in the fasted sate followed by dosing after a low-fat meal	Drug: sitravatinib; 100 mg sitravatinib on Day 1 of each of 3 periods
Experimental: Fed dosing (high-fat) followed by fed dosing (low-fat) followed by dosing in the fasted state; Fed dosing (high-fate meal) followed by fed dosing (low-fate meal) followed by dosing in the fasted state	Drug: sitravatinib; 100 mg sitravatinib on Day 1 of each of 3 periods
Experimental: Fed dosing (low-fat) followed dosing in the fasted state followed by fed dosing (high fat); Fed dosing (low-fat) meal followed dosing in the fasted state followed by fed dosing (high-fat meal)	Drug: sitravatinib; 100 mg sitravatinib on Day 1 of each of 3 periods
Experimental: Fed dosing (low-fat) followed by fed dosing (high-fat) followed by dosing in the fasted state; Fed dosing after a low-fat and high-fate meals followed by dosing in the fasted state	Drug: sitravatinib; 100 mg sitravatinib on Day 1 of each of 3 periods

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics - AUC∞ (sitravatinib)	Area under the plasma concentration-time curve from time zero extrapolated to infinity	Up to 72 hours after dosing
Pharmacokinetics - Cmax (sitravatinib)	Maximum observed plasma concentration	Up to 72 hours after dosing
Pharmacokinetics - AUClast (sitravatinib)	AUC from time zero to the last measured time point	Up to 72 hours after dosing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events (AEs)	Incidence and severity of adverse events (AEs) dosed in the fasted and fed states in healthy adult subjects	Up to 44 days

Collaborators and Investigators

• Sponsor: Mirati Therapeutics Inc.
• Investigators: Study Director: Curtis Chin, MD, Mirati Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2021
• Primary Completion (Actual): July 6, 2021
• Study Completion (Actual): March 28, 2022

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 12, 2021
• First Posted (Actual): March 16, 2021

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 516-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No