Recruiting
Phase 1

Adagrasib

Sponsor:

Mirati Therapeutics Inc.

Code:

NCT07723118

Conditions

Healthy Participants

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

Adagrasib

Study Details

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

Study ID

NCT07723118

Start date

Aug 5, 2026

Status verified date

Aug, 2026

Completion date

Sep 12, 2026

Anticipated

Primary completion date

Sep 8, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

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 Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Adagrasib

Interventions

Adagrasib

Specified dose on specified days

Primary outcome measure

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

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

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

Locations

CenExel ACT (Formerly Anaheim Clinical Trials; LLC)

Recruiting

Anaheim, California, United States, 92801

More Information

Sponsor

Mirati Therapeutics Inc.

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

  • Japanese Descent
  • Phase 1

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mirati Therapeutics Inc. on 2026-08-24.