Skip to main content
OpenTrials
Completed

NCT Number: NCT04800614

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit, Inc.

Dallas, Texas, 75247, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sitravatinib

Drug

100 mg sitravatinib on Day 1 of each of 3 periods

Primary outcomes

  1. Pharmacokinetics - Cmax (sitravatinib)

    Time frame: Up to 72 hours after dosing

    Maximum observed plasma concentration

  2. Pharmacokinetics - AUC∞ (sitravatinib)

    Time frame: Up to 72 hours after dosing

    Area under the plasma concentration-time curve from time zero extrapolated to infinity

  3. Pharmacokinetics - AUClast (sitravatinib)

    Time frame: Up to 72 hours after dosing

    AUC from time zero to the last measured time point

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Mirati Therapeutics Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Mar 16, 2021
Registry last updated
Apr 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.