COMPLETED

Bioequivalence Study Between Adagrasib Reference Tablets and High Drug Load Tablets

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-02-04

Study Completion:2025-06-19

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06801418

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.

Ages Eligible for Study:18 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Principal Investigator

Bristol-Myers Squibb

STUDY_DIRECTOR

Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 0003

Lenexa, Kansas, 66219-9746

United States

Local Institution - 0002

San Antonio, Texas, 78209-1028

United States

Local Institution - 0001

Salt Lake City, Utah, 84124-1365

United States

Collaborators and Investigators

Sponsor: Mirati Therapeutics Inc.

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-04

Study Completion Date2025-06-19

Study Record Updates

Study Start Date2025-02-04

Study Completion Date2025-06-19

Terms related to this study

Additional Relevant MeSH Terms

Healthy Volunteers