Search > Healthy Subjects
10 Participants NeededMy employer runs this trial

Adagrasib for Healthy Subjects

Recruiting at 1 trial location
Fl
Overseen ByFirst line of the email MUST contain NCT # and Site #.
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Mirati Therapeutics Inc.
Disqualifiers: Metabolic, Cardiovascular, Neurological, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

BS

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for healthy adults of Japanese descent (both parents are ethnically Japanese), aged with a BMI between 18 and 32, and weighing at least 50 kg. Participants must have no significant health issues or abnormal test results.

Inclusion Criteria

Participants must be healthy adults without clinically significant deviation from normal in medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory assessments as determined by the investigator
Participants must be of Japanese descent (both biological parents of the participant are ethnically Japanese)
Participants must have Body mass index of 18.0 kg/m2 to 32.0 kg/m2
See 1 more

Exclusion Criteria

Other protocol defined Inclusion/Exclusion criteria apply
I do not have any serious ongoing health conditions in major body systems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single dose of Adagrasib (BMS-986503)

Single dose

Follow-up

Participants are monitored for safety and pharmacokinetics after receiving the single dose

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Adagrasib

Trial Overview

The study tests how the body processes a single dose of Adagrasib in healthy Japanese participants. It also looks at safety and tolerability after taking the drug.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: AdagrasibExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mirati Therapeutics Inc.

Lead Sponsor

Trials
73
Recruited
8,900+

Dr. Charles M. Baum

Mirati Therapeutics Inc.

Chief Executive Officer since 2023

MD, PhD

Dr. Joseph Leveque

Mirati Therapeutics Inc.

Chief Medical Officer since 2021

MD

Unbiased Results

We believe in providing patients with all the options.

Your Data Stays Your Data

We only share your information with the clinical trials you're trying to access.

Verified Trials Only

All of our trials are run by licensed doctors, researchers, and healthcare companies.