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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RNK08954 Treatment A | Experimental | 1200mg RNK08954, following an overnight fast of at least 10 hours |
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| RNK08954 Treatment B | Experimental | 1200mg RNK08954, administered 30 minutes after the start of a high-fat/high-calorie meal breakfast. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RNK08954 | Drug | KRAS G12D inhibitor |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | 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. | 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 | 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 | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Wu | Contact | 86-0571-86630936 | xinwu@ranoktherapeutics.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui Central Hospital | Shanghai | China |
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| Electrocardiogram (ECG) parameters: HR, PR, QRS, QT, and QTc |
Safety and tolerability measures will be recorded at the indicated timepoints |
| 30 days |
| Systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHG) | Safety and tolerability measures will be recorded at the indicated timepoints | 30 days |