A Study to Assess the Pharmacokinetics, Safety and Tolerability of Single-dose Adagrasib (BMS-986503) in Healthy Participants of Japanese Descent

A Phase 1, Single-dose, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Adagrasib (BMS-986503) in Healthy Participants of Japanese Descent

The aim of this study is to assess the pharmacokinetics, safety and tolerability of single-dose Adagrasib (BMS-986503) in healthy participants of Japanese descent

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Adagrasib

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: First line of the email MUST contain NCT # and Site #.
• Study Contact Backup: Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Local Institution - 0001
      • Contact: Site 0001

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Participants must be of Japanese descent (both biological parents of the participant are ethnically Japanese).
• Participants must be healthy adult without clinically significant deviation from normal in medical history, PE, 12-lead ECG, vital sign measurements, and clinical laboratory assessments as determined by the investigator.
• Participants must have Body mass index of 18.0 kg/m2 to 32.0 kg/m2.
• Participants must have Total body weight ≥ 50 kg.

Exclusion Criteria:

• Participants must not have 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.
• Other protocol defined Inclusion/Exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum Observed Plasma Concentration (Cmax)	Up to Day 7
Time of Maximum Observed Plasma Concentration	Up to Day 7
Area Under the Plasma Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)]	Up to Day 7
Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)]	Up to Day 7
Apparent Terminal Phase Half-life (T-HALF)	Up to Day 7
Apparent Total Body Clearance (CLT/F)	Up to Day 7
Volume of Distribution of Terminal Phase (Vz/F)	Up to Day 7

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Treatment Emergent Adverse Events (AEs)	Up to Day 13
Number of Participants with Clinical Laboratory Test Abnormalities	Up to Day 7
Number of Participants with Vital Sign Abnormalities	Up to Day 7
Number of Participants with Physical Examination (PE) Abnormalities	Up to Day 7
Number of Participants with 12-Lead Electrocardiogram (ECG) Abnormalities	Up to Day 7

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 (Estimated): August 5, 2026
• Primary Completion (Estimated): September 8, 2026
• Study Completion (Estimated): September 12, 2026

Study Registration Dates

• First Submitted: July 20, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Phase 1; Japanese Descent
• Additional Relevant MeSH Terms: adagrasib
• Other Study ID Numbers: CA239-0028

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.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