Comparing two types of adagrasib tablets in healthy adults

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 study tests if two different types of adagrasib tablets work the same way in healthy adults.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Mirati Therapeutics Inc. (Industry-sponsored)
• Locations: 3 sites (Lenexa, Kansas and 2 other locations)
• Trial ID: NCT06801418 on ClinicalTrials.gov

What this trial studies

This study evaluates the bioequivalence of adagrasib reference tablets and high drug load tablets in healthy adult participants. It involves administering both formulations to assess how they perform in the body, ensuring that they have similar effects. The study aims to confirm that the high drug load tablets can be used interchangeably with the reference tablets. Healthy volunteers will undergo various assessments to ensure they meet the eligibility criteria before participation.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 to 65 with a BMI between 18.0 and 32.0 kg/m².

Not a fit: Patients with significant medical history deviations or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide evidence that high drug load adagrasib tablets are as effective as the reference tablets, potentially improving treatment options.

How similar studies have performed: Other studies have shown success in evaluating bioequivalence for similar drug formulations, indicating that this approach is well-established.

Eligibility criteria

Inclusion Criteria:

* 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:

  1. Is not an IOCBP, OR
  2. Is an IOCBP and using a non-hormonal contraceptive method that is highly effective (with a failure rate of \< 1% per year).

Exclusion Criteria:

* 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:

  i. 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.

Where this trial is running

Lenexa, Kansas and 2 other locations

• ICON - Lenexa — Lenexa, Kansas, United States (Recruiting)
• ICON Development Solutions — San Antonio, Texas, United States (Recruiting)
• ICON - Salt Lake City — Salt Lake City, Utah, United States (Recruiting)

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Conditions Healthy Volunteers