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

NCT07723118 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: CA239-0028
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Participants

Keywords

Japanese Descent; Phase 1

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (5)

• 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

Study Arms (1)

Adagrasib

EXPERIMENTAL

Drug: Adagrasib

Interventions

Adagrasib DRUG

Specified dose on specified days

Also known as: BMS-986503, MRTX849

Adagrasib

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mirati Therapeutics Inc.: lead

Study Sites (1)

Local Institution - 0001

Anaheim, California, 92801, 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

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

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

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 23, 2026
• Study Start (Estimated): August 5, 2026
• Primary Completion (Estimated): September 8, 2026
• Study Completion (Estimated): September 12, 2026
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

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

Locations

US (1)