Bioequivalence Study Between Adagrasib Reference Tablets and High Drug Load Tablets

Phase 1

Recruiting

• Conditions: Healthy Volunteers
• Interventions: Drug: Adagrasib

• Registration Number: NCT06801418
• Lead Sponsor: Mirati Therapeutics Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-24
• Study First Submitted QC: 2025-01-24
• Study First Posted: 2025-01-30
• Status Verified: 2025-02
• Study Start: 2025-02-04
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-28
• Primary Completion: 2025-05-30
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Adagrasib sequence A	Adagrasib	-
Adagrasib sequence B	Adagrasib	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Time of Maximum Observed Plasma Concentration (Tmax)	Up to Day 28
Apparent Terminal Phase Half-life (T-HALF)	Up to 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
Number of Participants with Clinical Laboratory Test Abnormalities	Up to Day 28
Number of Participants with Vital Sign Abnormalities	Up to Day 28
Number of Participants with Physical Examination Abnormalities	On Day 28

Trial Locations

Locations (3)

ICON - Lenexa; 🇺🇸 Lenexa, Kansas, United States

ICON Development Solutions; 🇺🇸 San Antonio, Texas, United States

ICON - Salt Lake City; 🇺🇸 Salt Lake City, Utah, United States