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Study of Adagrasib in Healthy Japanese Participants

This study is looking at a single dose of Adagrasib (BMS-986503) in healthy volunteers of Japanese descent. Researchers want to understand how the body processes the drug (pharmacokinetics), and if it is safe and well-tolerated. They will measure the highest amount of the drug in your blood (Maximum Observed Plasma Concentration or Cmax) and how long it takes to reach that level, as well as the total amount of drug in your system over time (Area Under the Plasma Concentration-time Curve). To join, you must be a healthy adult of Japanese descent, between 18 and 60 years old. The study aims to enroll 10 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 10 healthy participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints for measuring drug levels are up to Day 7 after receiving the dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07723118

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

Not Yet Recruiting
PHASE1Ages 18–60InterventionalTreatment
Mirati Therapeutics Inc.
~10 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:Adagrasib

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum Observed Plasma Concentration (Cmax)
Measured over Up to Day 7
+6 more outcomes measured

Conditions

Healthy Participants

Explore related trials

Healthy Volunteers

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Maximum Observed Plasma Concentration (Cmax)Up to Day 7
  • Time of Maximum Observed Plasma ConcentrationUp 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