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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Adagrasib |
|
Recruiting Locations
CenExel ACT (Formerly Anaheim Clinical Trials; LLC)
Anaheim, California 92801
Anaheim, California 92801
Contact:
Peter Winkle, Site 0001
Peter Winkle, Site 0001
More Details
- Status
- Recruiting
- Sponsor
- Mirati Therapeutics Inc.
Study Contact
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com855-907-3286
Clinical.Trials@bms.com