A Phase 1, Open-label, Multiple-dose, One-sequence Crossover Study to Investigate the Effect of Repeated Oral Doses of a Strong CYP2C8 Inhibitor on the Steady-state Pharmacokinetics of Adagrasib in Healthy Adult Subjects

Mirati Therapeutics Inc.1 site in 1 country18 target enrollmentJune 1, 2023

ConditionsHealthy Adults

DrugsTreatment A Treatment B

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy Adults
Sponsor: Mirati Therapeutics Inc.
Enrollment: 18
Locations: 1
Primary Endpoint: Pharmacokinetics - AUC (adagrasib)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A Phase 1, Open-label, Multiple-dose, One-sequence Crossover Study to Investigate the Effect of Repeated Oral Doses of a Strong CYP2C8 Inhibitor on the Steady-state Pharmacokinetics of Adagrasib in Healthy Adult Subjects

Registry

clinicaltrials.gov

Start Date

June 1, 2023

End Date

August 7, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Mirati Therapeutics Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males or females, of any race, between 18 and 60 years of age, inclusive, at Screening.
•Body mass index between 18.0 and 32.0 kg/m2, inclusive, at Screening.
•In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, or clinical laboratory evaluations at Screening and Check-in as assessed by the Investigator.
•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 informed consent form (ICF) and to abide by the study restrictions.

Exclusion Criteria

•Significant history or clinical manifestation of any metabolic, allergic, dermatological, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator.
•History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, any components of the investigational product (IP), or other substance (not including seasonal allergies).
•History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications.
•Significant history or clinical manifestation of any hepatic disease.
•History or current diagnosis of uncontrolled or significant cardiac disease.
•Ventricular dysfunction or history of risk factors for Torsades de Pointes.
•History of allergic reaction to fibric acid derivatives.
•History of drug abuse within 2 years prior to Screening.
•History of alcohol abuse within 12 months prior to Screening.
•Use of tobacco- or nicotine-containing products within 3 months prior to Check-in.