Bioequivalence Study Between Adagrasib Reference Tablets and High Drug Load Tablets

NCT06801418 | Completed Phase 1 FDA Drug

• 1 other identifier: CA239-0020
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Area Under the Plasma Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)]

  Up to Day 28

• Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)]

  Up to Day 28

• Maximum Observed Plasma Concentration (Cmax)

  Up to Day 28

Secondary Outcomes (7)

• Number of Participants with Treatment Emergent Adverse Events (AEs)

  Up to Day 34

• Number of Participants with Clinical Laboratory Test Abnormalities

  Up to Day 28

• Number of Participants with Vital Sign Abnormalities

  Up to Day 28

• Number of Participants with Physical Examination Abnormalities

  On Day 28

• Number of Participants with 12-Lead Electrocardiogram (ECG) Abnormalities

  Up to Day 28

Study Arms (2)

Adagrasib sequence A

EXPERIMENTAL

Drug: Adagrasib

Adagrasib sequence B

EXPERIMENTAL

Drug: Adagrasib

Interventions

Adagrasib DRUG

Specified dose on specified days

Also known as: BMS-986503, MRTX849

Adagrasib sequence A; Adagrasib sequence B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• Is not an IOCBP, OR
• Is an IOCBP and using a non-hormonal contraceptive method that is highly effective (with a failure rate of \< 1% per year).

You may not qualify if:

• 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:
• i. History of myocardial infarction ii. Heart failure iii. Unstable angina (within 6 months of Day -1) iv. High-risk or symptomatic cardiac arrhythmias (eg, sustained ventricular tachycardia, second- or third-degree atrioventricular block without a pacemaker) v. Hypertension.

Sponsors & Collaborators

• Mirati Therapeutics Inc.: lead

Study Sites (3)

Local Institution - 0003

Lenexa, Kansas, 66219-9746, United States

Location

Local Institution - 0002

San Antonio, Texas, 78209-1028, United States

Location

Local Institution - 0001

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

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Interventions

adagrasib

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: January 30, 2025
• Study Start: February 4, 2025
• Primary Completion: June 19, 2025
• Study Completion: June 19, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

US (3)