Bioequivalence Study Between Adagrasib Reference Tablets and High Drug Load Tablets
- Summary
- This is a study to evaluate bioequivalence between adagrasib reference tablets and high drug load tablets in healthy adult participants.
- Short title
- Bioequivalence Study Between Adagrasib Reference Tablets and High Drug Load Tablets
- 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2025-06-19
- First posted
- 2025-01-30
- Registry last updated
- 2025-07-16
- Primary completion date
- 2025-06-19
- Start date
- 2025-02-04
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Mirati Therapeutics Inc.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06801418
- ClinicalTrials.gov ID
- NCT06801418
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Crossover
- Purpose
- Treatment
- Masking
- No masking
Area Under the Plasma Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)]
Timeframe: Up to Day 28
Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)]
Timeframe: Up to Day 28
Maximum Observed Plasma Concentration (Cmax)
Timeframe: Up to Day 28
Number of Participants with Treatment Emergent Adverse Events (AEs)
Timeframe: Up to Day 34
Number of Participants with Clinical Laboratory Test Abnormalities
Timeframe: Up to Day 28
Number of Participants with Vital Sign Abnormalities
Timeframe: Up to Day 28
Number of Participants with Physical Examination Abnormalities
Timeframe: On Day 28
Number of Participants with 12-Lead Electrocardiogram (ECG) Abnormalities
Timeframe: Up to Day 28
Time of Maximum Observed Plasma Concentration (Tmax)
Timeframe: Up to Day 28
Apparent Terminal Phase Half-life (T-HALF)
Timeframe: Up to Day 28
- Sex
- All
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 60 Years
- Healthy volunteers
- Yes
-
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).
-
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.
- Local Institution - 0003Lenexa, United States
- Local Institution - 0002San Antonio, United States
- Local Institution - 0001Salt Lake City, United States
- Related resource (www.bms.com)
- Related resource (www.bmsclinicaltrials.com)