Bioequivalence Study Between Adagrasib Reference Tablets and High Drug Load Tablets

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-04

Study Completion Date

2025-06-19

Brief Summary

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

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Adagrasib sequence A

Group Type EXPERIMENTAL

Adagrasib

Intervention Type DRUG

Specified dose on specified days

Adagrasib sequence B

Group Type EXPERIMENTAL

Adagrasib

Intervention Type DRUG

Specified dose on specified days

Interventions

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Adagrasib

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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BMS-986503 MRTX849

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes