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

Healthy Adults Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04800614
• Other study ID #: 516-009
• Status: Completed
• Phase: Phase 1
• Start date: March 15, 2021
• Est. completion date: March 28, 2022

Study information

• Verified date: April 2022
• Source: Mirati Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 28, 2022
• Est. primary completion date: July 6, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Adults

Intervention

Drug:
• sitravatinib
100 mg sitravatinib on Day 1 of each of 3 periods

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit, Inc.	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Mirati Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics - Cmax (sitravatinib)	Maximum observed plasma concentration	Up to 72 hours after dosing
Primary	Pharmacokinetics - AUC8 (sitravatinib)	Area under the plasma concentration-time curve from time zero extrapolated to infinity	Up to 72 hours after dosing
Primary	Pharmacokinetics - AUClast (sitravatinib)	AUC from time zero to the last measured time point	Up to 72 hours after dosing
Secondary	Adverse Events (AEs)	Incidence and severity of adverse events (AEs) dosed in the fasted and fed states in healthy adult subjects	Up to 44 days