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

• ClinicalTrials.gov Identifier: NCT04800614
• Recruitment Status: Active, not recruiting
• First Posted: March 16, 2021
• Last Update Posted: November 29, 2021
• Sponsor: Mirati Therapeutics Inc.
• Information provided by (Responsible Party): Mirati Therapeutics Inc.

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
Healthy Adults	Drug: sitravatinib	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Three 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: March 15, 2021
• Actual Primary Completion Date: July 6, 2021
• Estimated Study Completion Date: February 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) [ 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 Outcome Measures :

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

Eligibility Criteria

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

Criteria

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

United States, Texas

Covance Clinical Research Unit, Inc.

Dallas, Texas, United States, 75247

Sponsors and Collaborators

Mirati Therapeutics Inc.

Investigators

• Study Director: Curtis Chin, MD; Mirati Therapeutics

More Information

• Responsible Party: Mirati Therapeutics Inc.
• ClinicalTrials.gov Identifier: NCT04800614
• Other Study ID Numbers: 516-009
• First Posted: March 16, 2021
• Last Update Posted: November 29, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No