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

Sponsor
Mirati Therapeutics Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04800614
Collaborator
(none)
36
1
6
12.4
2.9

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Three Period CrossoverThree Period Crossover
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Mar 15, 2021
Actual Primary Completion Date :
Jul 6, 2021
Actual Study Completion Date :
Mar 28, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Pharmacokinetics - Cmax (sitravatinib) [Up to 72 hours after dosing]

    Maximum observed plasma concentration

  2. Pharmacokinetics - AUC∞ (sitravatinib) [Up to 72 hours after dosing]

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

  3. Pharmacokinetics - AUClast (sitravatinib) [Up to 72 hours after dosing]

    AUC from time zero to the last measured time point

Secondary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Covance Clinical Research Unit, Inc. Dallas Texas United States 75247

Sponsors and Collaborators

  • Mirati Therapeutics Inc.

Investigators

  • Study Director: Curtis Chin, MD, Mirati Therapeutics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mirati Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT04800614
Other Study ID Numbers:
  • 516-009
First Posted:
Mar 16, 2021
Last Update Posted:
Apr 6, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 6, 2022