This is a study to evaluate bioequivalence between adagrasib reference tablets and high drug load tablets in healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
Specified dose on specified days
Local Institution - 0003
Lenexa, Kansas, United States
Local Institution - 0002
San Antonio, Texas, United States
Local Institution - 0001
Salt Lake City, Utah, United States
Area Under the Plasma Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)]
Time frame: Up to Day 28
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
Maximum Observed Plasma Concentration (Cmax)
Time frame: Up to Day 28
Number of Participants with Treatment Emergent Adverse Events (AEs)
Time frame: Up to Day 34
Number of Participants with Clinical Laboratory Test Abnormalities
Time frame: Up to Day 28
Number of Participants with Vital Sign Abnormalities
Time frame: Up to Day 28
Number of Participants with Physical Examination Abnormalities
Time frame: On Day 28
Number of Participants with 12-Lead Electrocardiogram (ECG) Abnormalities
Time frame: Up to Day 28
Time of Maximum Observed Plasma Concentration (Tmax)
Time frame: Up to Day 28
Apparent Terminal Phase Half-life (T-HALF)
Time frame: Up to Day 28
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