Bioequivalence Study Between Adagrasib Reference Tablets and High Drug Load Tablets

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Adagrasib

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Lenexa, Kansas, United States, 66219-9746
      • Local Institution - 0003
  • Texas
    • San Antonio, Texas, United States, 78209-1028
      • Local Institution - 0002
  • Utah
    • Salt Lake City, Utah, United States, 84124-1365
      • Local Institution - 0001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion 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).

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 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.

• Other protocol-defined Inclusion/Exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adagrasib sequence A	Drug: Adagrasib; Specified dose on specified days; Other Names: MRTX849; BMS-986503
Experimental: Adagrasib sequence B	Drug: Adagrasib; Specified dose on specified days; Other Names: MRTX849; BMS-986503

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Vital Sign Abnormalities	Up to Day 28
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 Physical Examination Abnormalities	On Day 28
Number of Participants with 12-Lead Electrocardiogram (ECG) Abnormalities	Up to Day 28
Time of Maximum Observed Plasma Concentration (Tmax)	Up to Day 28
Apparent Terminal Phase Half-life (T-HALF)	Up to Day 28

Collaborators and Investigators

• Sponsor: Mirati Therapeutics Inc.
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2025
• Primary Completion (Actual): June 19, 2025
• Study Completion (Actual): June 19, 2025

Study Registration Dates

• First Submitted: January 24, 2025
• First Submitted That Met QC Criteria: January 24, 2025
• First Posted (Actual): January 30, 2025

Study Record Updates

• Last Update Posted (Actual): July 16, 2025
• Last Update Submitted That Met QC Criteria: July 11, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antineoplastic Agents; Adagrasib
• Other Study ID Numbers: CA239-0020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.

Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at:

https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

• IPD Sharing Time Frame: See plan description
• IPD Sharing Access Criteria: See plan description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No