Healthy VolunteersPhase 1NCT06801418
Bioequivalence Study Between Adagrasib Reference Tablets and High Drug Load Tablets
A Phase 1 study testing Adagrasib in people with Healthy Volunteers, run by Mirati Therapeutics Inc. at 3 sites in United States.
Trial summary
This is a study to evaluate bioequivalence between adagrasib reference tablets and high drug load tablets in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Adagrasib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 Feb 2025to 19 Jun 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult participants 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.
- Body mass index of 18.0 kg/m2 to 32.0 kg/m^2, inclusive, (BMI may be rounded, eg, a participant with a BMI of 32.4 kg/m^2 would qualify; a participant with a BMI of 32.5 kg/m^2 or higher would not qualify). BMI = weight (kg)/(height [m])^2.
- Total body weight ≥ 50 kg.
- Individuals of childbearing potential (IOCBP) and male (as assigned at birth) participants who are sexually active with IOCBP must agree to follow instructions for method(s) of contraception as included in the ICF.
- A female (as assigned at birth) is eligible to participate if she is not pregnant or breastfeeding and at least 1 of the following conditions applies:
- Is not an IOCBP, OR
- Is an IOCBP and using a non-hormonal contraceptive method that is highly effective (with a failure rate of < 1% per year).
Who cannot join
- 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.
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, any components of the IMP, or other substance (not including seasonal allergies), unless approved by the investigator and medical monitor.
- History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions.
- History or current diagnosis of uncontrolled or significant cardiac disease indicating significant risk of safety for participation in the study, including any of the following:
- History of myocardial infarction ii. Heart failure iii. Unstable angina (within 6 months of Day -1) iv. High-risk or symptomatic cardiac arrhythmias (eg, sustained ventricular tachycardia, second- or third-degree atrioventricular block without a pacemaker) v. Hypertension.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Local Institution - 0003
Lenexa, Kansas, 66219-9746
Local Institution - 0001
Salt Lake City, Utah, 84124-1365
Local Institution - 0002
San Antonio, Texas, 78209-1028
About this study
Official title: A Phase 1, Open-label, Randomized, 2-sequence, 4-period, Fully-replicate, Bioequivalence Study Between Adagrasib Reference Tablets and High Drug Load Tablets in Healthy Adult Participants
This is a study to evaluate bioequivalence between adagrasib reference tablets and high drug load tablets in healthy adult participants.
- Conditions
- Healthy Volunteers
- Being tested
- Adagrasib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdagrasibDrug
Also called BMS-986503, MRTX849
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Adagrasib sequence A | Experimental | Not described Receives: Drug: Adagrasib |
| Adagrasib sequence B | Experimental | Not described Receives: Drug: Adagrasib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)]
Measured: Up to Day 28
Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)]
Measured: Up to Day 28
Maximum Observed Plasma Concentration (Cmax)
Measured: Up to Day 28
Secondary outcomes (7)
Number of Participants with Treatment Emergent Adverse Events (AEs)
Measured: Up to Day 34
Number of Participants with Clinical Laboratory Test Abnormalities
Measured: Up to Day 28
Number of Participants with Vital Sign Abnormalities
Measured: Up to Day 28
Number of Participants with Physical Examination Abnormalities
Measured: On Day 28
Number of Participants with 12-Lead Electrocardiogram (ECG) Abnormalities
Measured: Up to Day 28
Time of Maximum Observed Plasma Concentration (Tmax)
Measured: Up to Day 28
Apparent Terminal Phase Half-life (T-HALF)
Measured: Up to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start4 Feb 2025
- Primary completion19 Jun 2025
- Study completion19 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mirati Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801418
- Sponsor's protocol ID
- CA239-0020
- Status last verified
- Jun 2025
- First submitted
- 24 Jan 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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/disclosurecommitment.html
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Randomized, 2-sequence, 4-period, Fully-replicate, Bioequivalence Study Between Adagrasib Reference Tablets and High Drug Load Tablets in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06801418
- Acronym / sponsor ID
- CA239-0020
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Mirati Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Feb 2025 (actual)
- Primary completion
- 19 Jun 2025 (actual)
- Study completion
- 19 Jun 2025 (actual)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to evaluate bioequivalence between adagrasib reference tablets and high drug load tablets in healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adagrasib sequence A | Experimental | Drug: Adagrasib |
| Adagrasib sequence B | Experimental | Drug: Adagrasib |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy adult participants 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.
- Body mass index of 18.0 kg/m2 to 32.0 kg/m^2, inclusive, (BMI may be rounded, eg, a participant with a BMI of 32.4 kg/m^2 would qualify; a participant with a BMI of 32.5 kg/m^2 or higher would not qualify). BMI = weight (kg)/(height [m])^2.
- Total body weight ≥ 50 kg.
- Individuals of childbearing potential (IOCBP) and male (as assigned at birth) participants who are sexually active with IOCBP must agree to follow instructions for method(s) of contraception as included in the ICF.
- A female (as assigned at birth) is eligible to participate if she is not pregnant or breastfeeding and at least 1 of the following conditions applies:
Key exclusion criteria (6 listed)
- 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.
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, any components of the IMP, or other substance (not including seasonal allergies), unless approved by the investigator and medical monitor.
- History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions.
- History or current diagnosis of uncontrolled or significant cardiac disease indicating significant risk of safety for participation in the study, including any of the following:
- Other protocol-defined Inclusion/Exclusion criteria apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdagrasibAlso: BMS-986503, MRTX849Specified dose on specified days | Drug | Adagrasib sequence A, Adagrasib sequence B |
Primary outcome
Area Under the Plasma Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)]
Time frame: Up to Day 28
Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)]
Time frame: Up to Day 28
Maximum Observed Plasma Concentration (Cmax)
Time frame: Up to Day 28
7 secondary outcomes
Number of Participants with Treatment Emergent Adverse Events (AEs)
Time frame: Up to Day 34
Number of Participants with Clinical Laboratory Test Abnormalities
Time frame: Up to Day 28
Number of Participants with Vital Sign Abnormalities
Time frame: Up to Day 28
Number of Participants with Physical Examination Abnormalities
Time frame: On Day 28
Number of Participants with 12-Lead Electrocardiogram (ECG) Abnormalities
Time frame: Up to Day 28
Time of Maximum Observed Plasma Concentration (Tmax)
Time frame: Up to Day 28
Apparent Terminal Phase Half-life (T-HALF)
Time frame: Up to Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: 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/disclosurecommitment.html
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Adagrasib in people with Healthy Volunteers, run by Mirati Therapeutics Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Plasma Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)] (time frame: Up to Day 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.