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Anaheim, California, 92801, United States
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NCT Number: NCT07723118
A Study to Assess the Pharmacokinetics, Safety and Tolerability of Single-dose 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
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Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year–60 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Adagrasib
DrugSpecified dose on specified days
Other names: BMS-986503, MRTX849
Primary outcomes
-
Maximum Observed Plasma Concentration (Cmax)
Time frame: Up to Day 7
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Time of Maximum Observed Plasma Concentration
Time frame: Up to Day 7
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Area Under the Plasma Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)]
Time frame: Up to Day 7
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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
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Apparent Terminal Phase Half-life (T-HALF)
Time frame: Up to Day 7
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Apparent Total Body Clearance (CLT/F)
Time frame: Up to Day 7
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Volume of Distribution of Terminal Phase (Vz/F)
Time frame: Up to Day 7
Secondary outcomes
-
Number of Participants with Treatment Emergent Adverse Events (AEs)
Time frame: Up to Day 13
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Number of Participants with Clinical Laboratory Test Abnormalities
Time frame: Up to Day 7
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Number of Participants with Vital Sign Abnormalities
Time frame: Up to Day 7
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Number of Participants with Physical Examination (PE) Abnormalities
Time frame: Up to Day 7
-
Number of Participants with 12-Lead Electrocardiogram (ECG) Abnormalities
Time frame: Up to Day 7
Study contacts
Contact information is provided by the study sponsor or research team.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
First line of the email MUST contain NCT # and Site #.
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Sponsors and collaborators
Lead sponsor
Mirati Therapeutics Inc.
Industry
Registry information
Official study title
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
Important dates
- Study start
- 2026
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Jul 23, 2026
- Registry last updated
- Jul 23, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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