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NCT07723118

Overview

NCT ID: NCT07723118
Lead Sponsor: Mirati Therapeutics Inc.INDUSTRY
Official 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
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
Interventions: Adagrasib

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: 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.

Central Contacts: BMS Clinical Trials Contact Center www.BMSClinicalTrials.comContact
Clinical.Trials@bms.com