Clinical trial NCT06801418: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Mirati Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2025-01-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Area Under the Plasma Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)]
timeFrame: Up to Day 28
measure: Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)]
timeFrame: Up to Day 28
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Up to Day 28
Secondary outcomes:
measure: Number of Participants with Treatment Emergent Adverse Events (AEs)
timeFrame: Up to Day 34
measure: Number of Participants with Clinical Laboratory Test Abnormalities
timeFrame: Up to Day 28
measure: Number of Participants with Vital Sign Abnormalities
timeFrame: Up to Day 28
measure: Number of Participants with Physical Examination Abnormalities
timeFrame: On Day 28
measure: Number of Participants with 12-Lead Electrocardiogram (ECG) Abnormalities
timeFrame: Up to Day 28
measure: Time of Maximum Observed Plasma Concentration (Tmax)
timeFrame: Up to Day 28
measure: Apparent Terminal Phase Half-life (T-HALF)
timeFrame: Up to Day 28
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: ICON - Lenexa
state: Kansas
city: San Antonio
country: United States
facility: ICON Development Solutions
state: Texas
city: Salt Lake City
country: United States
facility: ICON - Salt Lake City
state: Utah
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: