A Phase 1, Open-label, One-sequence Crossover Study to Investigate the Effect of a Breast Cancer Resistance Protein Inhibitor on the Single-dose Pharmacokinetics of Adagrasib in Healthy Adult Subjects
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
16
Adagrasib
Eltrombopag + adagrasib
Fortrea Clinical Research Unit Daytona Beach (Labcorp Clinical Research Unit Daytona Beach)
Daytona Beach, Florida, United States
Pharmacokinetics - AUC (adagrasib)
Area under the plasma concentration-time curve (AUC) from time zero to infinity (AUC∞)
Time frame: Days 1 and 8
Pharmacokinetics - AUC (adagrasib)
AUC from time zero to the last quantifiable concentration (AUClast)
Time frame: Days 1 and 8
Pharmacokinetics - Cmax (adagrasib)
Maximum observed plasma concentration (Cmax)
Time frame: Days 1 and 8
Pharmacokinetics - Tmax (adagrasib)
Time to reach Cmax (tmax)
Time frame: Days 1 and 8
Pharmacokinetics - t1/2 (adagrasib)
Elimination half-life (t1/2)
Time frame: Days 1 and 8
Pharmacokinetics - CL/F (adagrasib)
Apparent total plasma clearance (CL/F)
Time frame: Days 1 and 8
Pharmacokinetics - Vz/F (adagrasib)
Apparent volume of distribution (Vz/F)
Time frame: Days 1 and 8
Adverse Events (AEs)
Incidence and severity of AEs
Time frame: Up to 8 weeks from screening
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