Adagrasib for Healthy Subjects

Recruiting at 5 trial locations

Overseen By BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Mirati Therapeutics Inc.

Disqualifiers: Cardiac disease, Gastrointestinal conditions, others

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is a study to evaluate bioequivalence between adagrasib reference tablets and high drug load tablets in healthy adult participants.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinator or your doctor.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for healthy adults with a BMI between 18.0 to 32.0, weighing at least 50 kg, and without significant health issues or allergies to drugs. Women must not be pregnant or breastfeeding and either not of childbearing potential or using effective non-hormonal contraception.

Inclusion Criteria

I am a healthy adult with no significant medical issues.

Body mass index of 18.0 kg/m2 to 32.0 kg/m^2, inclusive (BMI may be rounded, eg, a participant with a BMI of 32.4 kg/m^2 would qualify; a participant with a BMI of 32.5 kg/m^2 or higher would not qualify)

Individuals of childbearing potential (IOCBP) and male participants who are sexually active with IOCBP must agree to follow instructions for method(s) of contraception as included in the ICF

Exclusion Criteria

History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, any components of the IMP, or other substance (not including seasonal allergies), unless approved by the investigator and medical monitor

I don't have major health issues in areas like metabolism, allergies, skin, kidneys, blood, lungs, heart, stomach, nerves, breathing, hormones, or mental health as judged by a doctor.

I have a history of serious stomach or bowel problems.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive adagrasib reference tablets and high drug load tablets to evaluate bioequivalence

4 periods

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Adagrasib (Monoclonal Antibodies)

Trial Overview The study is testing whether high drug load tablets of Adagrasib are equivalent in the body to the standard reference tablets when taken by healthy individuals.

Participant Groups

Group I: Adagrasib sequence B Experimental Treatment 1 Intervention

Group II: Adagrasib sequence A Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Mirati Therapeutics Inc.

Lead Sponsor

Trials

73

Recruited

8,900+

Dr. Charles M. Baum

Mirati Therapeutics Inc.

Chief Executive Officer since 2023

MD, PhD

Dr. Joseph Leveque

Mirati Therapeutics Inc.

Chief Medical Officer since 2021

MD