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

April 4, 2022 updated by: Mirati Therapeutics Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetics - AUC∞ (sitravatinib)
Time Frame: Up to 72 hours after dosing
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Up to 72 hours after dosing
Pharmacokinetics - Cmax (sitravatinib)
Time Frame: Up to 72 hours after dosing
Maximum observed plasma concentration
Up to 72 hours after dosing
Pharmacokinetics - AUClast (sitravatinib)
Time Frame: Up to 72 hours after dosing
AUC from time zero to the last measured time point
Up to 72 hours after dosing

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse Events (AEs)
Time Frame: Up to 44 days
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mirati Therapeutics Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Curtis Chin, MD, Mirati Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 6, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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