Healthy Volunteers
Conditions
Brief summary
This is a study to evaluate bioequivalence between adagrasib reference tablets and high drug load tablets in healthy adult participants.
Interventions
DRUGAdagrasib
Specified dose on specified days
Sponsors
Mirati Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Plasma Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)] | Up to Day 28 |
| Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)] | Up to Day 28 |
| Maximum Observed Plasma Concentration (Cmax) | Up to Day 28 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with Physical Examination Abnormalities | On Day 28 |
| Number of Participants with 12-Lead Electrocardiogram (ECG) Abnormalities | Up to Day 28 |
| Number of Participants with Treatment Emergent Adverse Events (AEs) | Up to Day 34 |
| Apparent Terminal Phase Half-life (T-HALF) | Up to Day 28 |
| Time of Maximum Observed Plasma Concentration (Tmax) | Up to Day 28 |
| Number of Participants with Clinical Laboratory Test Abnormalities | Up to Day 28 |
| Number of Participants with Vital Sign Abnormalities | Up to Day 28 |
Countries
United States
Outcome results
None listed