ClinicalTrials.gg
CompletedNCT07723118Updated Sep 28, 2026

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

A Phase 1 interventional study of Adagrasib in Healthy Participants, sponsored by Mirati Therapeutics Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Mirati Therapeutics Inc. (part of Bristol-Myers Squibb) · Phase 1, Interventional, and Treatment

Updated Sep 28, 2026Now CompletedStudy completion moved+3 moreGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study 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

02

Conditions studied

  • Healthy Participants

Keywords

  • Japanese Descent
  • Phase 1
03

In context

Lead sponsor

Mirati Therapeutics Inc. is the lead sponsor of 51 studies on the registry; 3 are open to participants now.

Of its 20 completed or terminated interventional studies of FDA-regulated products, 4 (20%) have results posted.

First submitted after Mirati Therapeutics Inc. became part of Bristol-Myers Squibb.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants must be of Japanese descent (both biological parents of the participant are ethnically Japanese).
  • Participants must be healthy adult without deviation from normal in medical history, PE, 12-lead , vital sign measurements, and clinical laboratory assessments as determined by the investigator.
  • Participants must have of 18.0 kg/m2 to 32.0 kg/m2.
  • Participants must have Total body weight ≥ 50 kg.

Exclusion criteria

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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Adagrasib

    Drug: Adagrasib

Interventions

  • Specified dose on specified days

    Also known as: BMS-986503, MRTX849

06

What researchers measure

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Up to Day 7

  2. Time of Maximum Observed Plasma Concentration

    Time frame: Up to Day 7

  3. Area Under the Plasma Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)]

    Time frame: Up to Day 7

  4. Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)]

    Time frame: Up to Day 7

  5. Apparent Terminal Phase Half-life (T-HALF)

    Time frame: Up to Day 7

  6. Apparent Total Body Clearance (CLT/F)

    Time frame: Up to Day 7

  7. Volume of Distribution of Terminal Phase (Vz/F)

    Time frame: Up to Day 7

Secondary outcomes

  1. Number of Participants with Treatment Emergent Adverse Events (AEs)

    Time frame: Up to Day 13

  2. Number of Participants with Clinical Laboratory Test Abnormalities

    Time frame: Up to Day 7

  3. Number of Participants with Vital Sign Abnormalities

    Time frame: Up to Day 7

  4. Number of Participants with Physical Examination (PE) Abnormalities

    Time frame: Up to Day 7

  5. Number of Participants with 12-Lead Electrocardiogram (ECG) Abnormalities

    Time frame: Up to Day 7

07

Study locations

1 site
  • Local Institution - 0001
    Anaheim, California 92801, United States
08

References and documents

Individual participant data

Plan to share: Yes — BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: See Plan Description

Access criteria: See Plan Description

Data sharing details ↗ · www.bms.com

09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Completed
changed Sep 28, 2026
Sites
1 site added, 1 site removed
Show site
  • Local Institution - 0001 · Anaheim, United States
Show 1 removed
  • CenExel ACT (Formerly Anaheim Clinical Trials; LLC) · Anaheim, United States
Sep 28, 2026
Study completion
Sep 12, 2026→Sep 14, 2026 (actual)
Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    Recruiting→Completed
    1 site added, 1 site removed
    Show site
    • Local Institution - 0001 · Anaheim, United States
    Show 1 removed
    • CenExel ACT (Formerly Anaheim Clinical Trials; LLC) · Anaheim, United States
    Study completion Sep 12, 2026→Sep 14, 2026 (now actual)
    + 3 other changes: verification date, contact details and references

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07723118
Responsible party
Sponsor
First posted
Jul 23, 2026
Start date
Aug 5, 2026
Primary completion
Sep 8, 2026
Completion
Sep 14, 2026
Last update
Sep 28, 2026

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Adagrasib

Start the discussion