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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07723118

Enrollment

Registered

2026-07-23

Start date

2026-08-05

Completion date

2026-09-12

Last updated

2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

Keywords

Japanese Descent, Phase 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

Interventions

DRUGAdagrasib

Specified dose on specified days

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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/

Design outcomes

Primary

Measure	Time frame
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
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

Secondary

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

Countries

United States

Contacts

CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Clinical.Trials@bms.com855-907-3286

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

STUDY_DIRECTORBristol-Myers Squibb

Bristol-Myers Squibb

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 25, 2026