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

NCT04800614 | Completed Phase 1 FDA Drug

• 1 other identifier: 516-009
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics - Cmax (sitravatinib)

  Maximum observed plasma concentration

  Up to 72 hours after dosing

• Pharmacokinetics - AUC∞ (sitravatinib)

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

  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 Outcomes (1)

• Adverse Events (AEs)

  Up to 44 days

Study Arms (6)

Fasted dosing followed by fed dosing (high-fat meal) followed by fed dosing (low-fat meal)

EXPERIMENTAL

Dosing in the fasted state followed by fed dosing after high and low fat meals

Drug: sitravatinib

Fasted dosing followed by fed dosing (low-fat meal) followed by fed dosing (high-fat meal)

EXPERIMENTAL

Dosing in the fasted state followed by fed dosing after low and high fat meals

Drug: sitravatinib

Fed dosing (high-fat meal) followed by fasted dosing followed by fed dosing (low-fat meal)

EXPERIMENTAL

Dosing after a high-fat meal followed by doing in the fasted sate followed by dosing after a low-fat meal

Drug: sitravatinib

Fed dosing (high-fat) followed by fed dosing (low-fat) followed by dosing in the fasted state

EXPERIMENTAL

Fed dosing (high-fate meal) followed by fed dosing (low-fate meal) followed by dosing in the fasted state

Drug: sitravatinib

Fed dosing (low-fat) followed dosing in the fasted state followed by fed dosing (high fat)

EXPERIMENTAL

Fed dosing (low-fat) meal followed dosing in the fasted state followed by fed dosing (high-fat meal)

Drug: sitravatinib

Fed dosing (low-fat) followed by fed dosing (high-fat) followed by dosing in the fasted state

EXPERIMENTAL

Fed dosing after a low-fat and high-fate meals followed by dosing in the fasted state

Drug: sitravatinib

Interventions

sitravatinib DRUG

100 mg sitravatinib on Day 1 of each of 3 periods

Fasted dosing followed by fed dosing (high-fat meal) followed by fed dosing (low-fat meal); Fasted dosing followed by fed dosing (low-fat meal) followed by fed dosing (high-fat meal); Fed dosing (high-fat meal) followed by fasted dosing followed by fed dosing (low-fat meal); Fed dosing (high-fat) followed by fed dosing (low-fat) followed by dosing in the fasted state; Fed dosing (low-fat) followed by fed dosing (high-fat) followed by dosing in the fasted state; Fed dosing (low-fat) followed dosing in the fasted state followed by fed dosing (high fat)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mirati Therapeutics Inc.: lead

Study Sites (1)

Covance Clinical Research Unit, Inc.

Dallas, Texas, 75247, United States

Location

MeSH Terms

Interventions

sitravatinib

Study Officials

• Curtis Chin, MD

  Mirati Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Three Period Crossover

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 16, 2021
• Study Start: March 15, 2021
• Primary Completion: July 6, 2021
• Study Completion: March 28, 2022
• Last Updated: April 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)