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
Healthy, adult, male or female, 18-45 years of age, inclusive, at the screening visit.
Male participants must have a body weight of no less than 50 kg, and female participants must have a body weight of no less than 45 kg. The Body mass index (BMI) should be between 19 and 26 kg/m² (inclusive).
Must follow protocol specified contraception guidance.
Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
Clinically significant abnormalities found in comprehensive physical examinations, vital signs, laboratory tests, 12-lead electrocardiogram, chest X-ray, etc.
Positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or treponema pallidum antibody.
Individuals with allergic constitution.
Any history of clinically significant diseases or conditions that, in the investigator's judgment, may affect the trial results.
Crossover
RNK08954
DrugKRAS G12D inhibitor
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)
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)
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.
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
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.
Electrocardiogram (ECG) parameters: HR, PR, QRS, QT, and QTc
Safety and tolerability measures will be recorded at the indicated timepoints
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHG)
Safety and tolerability measures will be recorded at the indicated timepoints
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