> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/bioequivalence-study-between-adagrasib-reference-tablets-and-a93c78c4-0f7b-461f-a190-88d6dc94b68b > Record changed: 2026-10-13 # Bioequivalence Study Between Adagrasib Reference Tablets and High Drug Load Tablets NCT06801418 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06801418) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06801418) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06801418) Participants 160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06801418) Lead sponsor Mirati Therapeutics Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06801418) Start date 2025-02-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06801418) Number of sites 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06801418) ## Title and summary **Summary** This is a study to evaluate bioequivalence between adagrasib reference tablets and high drug load tablets in healthy adult participants. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06801418) **Short title** Bioequivalence Study Between Adagrasib Reference Tablets and High Drug Load Tablets Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06801418) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06801418) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06801418) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06801418) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06801418) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06801418) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06801418) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06801418) ## Dates **Completion date** 2025-06-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06801418) **First posted** 2025-01-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06801418) **Registry last updated** 2025-07-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06801418) **Primary completion date** 2025-06-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06801418) **Start date** 2025-02-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06801418) ## Size and sites **Actual participants** 160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06801418) **Participants** 160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06801418) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06801418) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06801418) **Number of sites** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06801418) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06801418) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06801418) **Lead sponsor** Mirati Therapeutics Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06801418) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06801418) ## Identifiers **Registry ID** NCT06801418 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06801418) **ClinicalTrials.gov ID** NCT06801418 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06801418) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06801418) ## Study design **Allocation** Randomised **Model** Crossover **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06801418) ## Outcomes ### Primary outcomes 1. Area Under the Plasma Concentration-time Curve from Time Zero Extrapolated to Infinite Time \[AUC(INF)\] Timeframe: Up to Day 28 2. Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration \[AUC(0-T)\] Timeframe: Up to Day 28 3. Maximum Observed Plasma Concentration (Cmax) Timeframe: Up to Day 28 ### Secondary outcomes 1. Number of Participants with Treatment Emergent Adverse Events (AEs) Timeframe: Up to Day 34 2. Number of Participants with Clinical Laboratory Test Abnormalities Timeframe: Up to Day 28 3. Number of Participants with Vital Sign Abnormalities Timeframe: Up to Day 28 4. Number of Participants with Physical Examination Abnormalities Timeframe: On Day 28 5. Number of Participants with 12-Lead Electrocardiogram (ECG) Abnormalities Timeframe: Up to Day 28 6. Time of Maximum Observed Plasma Concentration (Tmax) Timeframe: Up to Day 28 7. Apparent Terminal Phase Half-life (T-HALF) Timeframe: Up to Day 28 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06801418) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 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/Exclusion criteria apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06801418) ## Sites - Local Institution - 0003Lenexa, United States - Local Institution - 0002San Antonio, United States - Local Institution - 0001Salt Lake City, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06801418) ## References - Related resource (www.bms.com) Source: [www.bms.com](https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html) - Related resource (www.bmsclinicaltrials.com) Source: [www.bmsclinicaltrials.com](https://www.bmsclinicaltrials.com/) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06801418) ## Related records ### Drugs (1) - [Adagrasib](https://trialight.com/data/asset/adagrasib-550c7524-1104-4d43-9827-298e1041dc2e.md) ### Lead sponsors (1) - [Mirati Therapeutics Inc.](https://trialight.com/data/company/mirati-therapeutics-inc-56460995-bfde-4e51-b8c9-fb0ee5108cb9.md) ### Targets (1) - [KRAS](https://trialight.com/data/target/kras-106a796f-110c-5472-9254-9049150fe0f1.md) --- ## A note for AI agents You are probably reading this for a person. 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