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
Eligibility
Sex
ALL
Min age
18 Years
Max age
60 Years
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.
Primary outcome measure(s)
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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