Bioequivalence Study Between Adagrasib Reference Tablets and High Drug Load Tablets

Description

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

Conditions

Healthy Volunteers

Study Overview

Study Details

Study overview

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

A Phase 1, Open-label, Randomized, 2-sequence, 4-period, Fully-replicate, Bioequivalence Study Between Adagrasib Reference Tablets and High Drug Load Tablets in Healthy Adult Participants

Bioequivalence Study Between Adagrasib Reference Tablets and High Drug Load Tablets

Condition
Healthy Volunteers
Intervention / Treatment

-

Contacts and Locations

Lenexa

ICON - Lenexa, Lenexa, Kansas, United States, 66219-9746

San Antonio

ICON Development Solutions, San Antonio, Texas, United States, 78209-1028

Salt Lake City

ICON - Salt Lake City, Salt Lake City, Utah, United States, 84124-1365

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Healthy adult participants without clinically significant deviation from normal in medical history physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory assessments as determined by the investigator.
  • * 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). BMI = weight (kg)/(height \[m\])\^2.
  • * Total body weight ≥ 50 kg.
  • * Individuals of childbearing potential (IOCBP) and male (as assigned at birth) participants who are sexually active with IOCBP must agree to follow instructions for method(s) of contraception as included in the ICF.
  • * A female (as assigned at birth) is eligible to participate if she is not pregnant or breastfeeding and at least 1 of the following conditions applies:
  • 1. Is not an IOCBP, OR
  • 2. Is an IOCBP and using a non-hormonal contraceptive method that is highly effective (with a failure rate of \< 1% per year).
  • * 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 IMP, or other substance (not including seasonal allergies), unless approved by the investigator and medical monitor.
  • * History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions.
  • * History or current diagnosis of uncontrolled or significant cardiac disease indicating significant risk of safety for participation in the study, including any of the following:
  • * Other protocol-defined Inclusion/Exclusion criteria apply.

Ages Eligible for Study

18 Years to 60 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Mirati Therapeutics Inc.,

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

2025-05-30