An Study of Orally Administered RNK08954 in Healthy Adult Subjects to Determine the Effect of Food on the Pharmacokinetics of RNK08954,Mass Balance Study of \[14C\] RNK08954 in Chinese Healthy Adult Male Subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
KRAS G12D inhibitor
Shanghai Xuhui Central Hospital
Shanghai, China
Plasma Pharmacokinetics (PK) of a single dose of RNK08954 after a standardized high-fat/high-calorie meal and after fasting: Tmax
Time of Maximum concentration (Tmax)
Time frame: 30 days
Plasma Pharmacokinetics (PK) of a single dose of RNK08954 after a standardized high-fat/high-calorie meal and after fasting: Tlag
absorption lag-time (Tlag)
Time frame: 30 days
Plasma Pharmacokinetics (PK) of a single dose of RNK08954 after a standardized high-fat/high-calorie meal and after fasting: Cmax
Cmax for RNK08954 administered with and without food.
Time frame: 30 days
Plasma Pharmacokinetics (PK) of a single dose of RNK08954 after a standardized high-fat/high-calorie meal and after fasting: AUC0-inf
Area under plasma Concentration (AUC) from zero to infinity
Time frame: 30 days
Plasma Pharmacokinetics (PK) of a single dose of RNK08954 after a standardized high-fat/high-calorie meal and after fasting: AUC0-last
Area Under the concentration-time Curve from time zero to the time of the last
Time frame: 30 days
Incidence,frequency and severity of adverse events (AEs)of RNK08954 as assessed by CTCAE 5.0
As a measure of the safety and tolerability of RNK08954 the number of subjects who experienced any treatment emergent AE (TEAE), any causally related AE, any serious AE (SAE), and any causally related SAE are presented.
Time frame: 30 days
Electrocardiogram (ECG) parameters: HR, PR, QRS, QT, and QTc
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Safety and tolerability measures will be recorded at the indicated timepoints
Time frame: 30 days
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHG)
Safety and tolerability measures will be recorded at the indicated timepoints
Time frame: 30 days