Bioequivalence Study Between Adagrasib Reference Tablets and High Drug Load Tablets

Mirati Therapeutics

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Adagrasib

Study type

Interventional

Funder types

Industry

Identifiers

CA239-0020

Details and patient eligibility

About

This is a study to evaluate bioequivalence between adagrasib reference tablets and high drug load tablets in healthy adult participants.

Enrollment

160 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.