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

Purpose

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

Condition

  • Healthy Participants

Eligibility

Eligible Ages
Between 18 Years and 60 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Adagrasib
  • Drug: Adagrasib
    Specified dose on specified days
    Other names:
    • BMS-986503
    • MRTX849

Recruiting Locations

CenExel ACT (Formerly Anaheim Clinical Trials; LLC)
Anaheim, California 92801
Contact:
Peter Winkle, Site 0001

More Details

Status
Recruiting
Sponsor
Mirati Therapeutics Inc.

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com