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Completed

NCT Number: NCT06801418

Bioequivalence Study Between Adagrasib Reference Tablets and High Drug Load Tablets

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

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0003, Lenexa, Kansas, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • 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).

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.

Treatment and study plan

Adagrasib

Drug

Specified dose on specified days

Other names: BMS-986503, MRTX849

Primary outcomes

  1. Area Under the Plasma Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)]

    Time frame: Up to Day 28

  2. Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)]

    Time frame: Up to Day 28

  3. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Up to Day 28

Secondary outcomes

  1. Number of Participants with Treatment Emergent Adverse Events (AEs)

    Time frame: Up to Day 34

  2. Number of Participants with Clinical Laboratory Test Abnormalities

    Time frame: Up to Day 28

  3. Number of Participants with Vital Sign Abnormalities

    Time frame: Up to Day 28

  4. Number of Participants with Physical Examination Abnormalities

    Time frame: On Day 28

  5. Number of Participants with 12-Lead Electrocardiogram (ECG) Abnormalities

    Time frame: Up to Day 28

  6. Time of Maximum Observed Plasma Concentration (Tmax)

    Time frame: Up to Day 28

  7. Apparent Terminal Phase Half-life (T-HALF)

    Time frame: Up to Day 28

Sponsors and collaborators

Lead sponsor

Mirati Therapeutics Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 30, 2025
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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