A Study to Evaluate the Food Effect on RNK08954 in Healthy Participants, and the Mass Balance Study of [14C]RNK08954 in Healthy Adult Male Subjects

A Study to Evaluate the Food Effect on the Pharmacokinetics of RNK08954 Tablets and to Assess the Mass Balance of [14C]RNK08954 in Healthy Adult Male Subjects in China

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 Overview

• Status: Not yet recruiting
• Conditions: Food Effect; Mass Balance
• Intervention / Treatment: Drug: RNK08954

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Xin Wu; Phone Number: 86-0571-86630936; Email: xinwu@ranoktherapeutics.com

Study Locations

• China
  • Shanghai, China
    • Shanghai Xuhui Central Hospital
    • Contact: YanMei Liu; Phone Number: 86-13564045062; Email: ymliu@shxh-centerlab.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• History or family history of organic heart disease, heart failure, myocardial infarction, angina pectoris, torsades de pointes, ventricular tachycardia, QT prolongation syndrome.
• Gastrointestinal diseases that cause clinically significant symptoms such as nausea, vomiting, diarrhea, or malabsorption syndrome, or those with a history of vomiting or diarrhea within one week prior to screening.
• Individuals with dysphagia.
• Undergone major surgery within six months prior to the first dose or whose surgical incision has not fully healed.
• Used investigational drugs or received other experimental treatments within three months prior to the first dose or are currently participating in any other interventional clinical trials.
• Vaccinated within one month prior to the first dose or plan to be vaccinated during the trial period.
• Used any drugs affecting drug-metabolizing enzymes or transporters within 30 days prior to the first dose.
• Taken any prescription drugs, over-the-counter medications, herbal medicines, or dietary supplements within 14 days prior to the first dose.
• Smoke more than 10 cigarettes per day or habitually use nicotine-containing products within three months prior to the first dose.
• Current or previous alcohol abuse, or frequent alcohol consumption within six months prior to the first dose, or those with a positive alcohol breath test.
• History of drug abuse, use of soft drugs within three months prior to the first dose, or use of hard drugs within one year prior to the first dose, or those with a positive urine drug abuse screening.
• Individuals who habitually or excessively consume grapefruit juice, tea, coffee, and/or caffeinated beverages.
• History of blood loss or blood donation (≥400 mL) within three months prior to the first dose, those who have received blood transfusions or blood products within one month prior to the first dose, or those who plan to donate blood within three months after the trial.
• Special dietary requirements, intolerance to high-fat meals, or inability to comply with a standardized diet.
• History of needle or blood phobia, difficulty with blood collection, or intolerance to venipuncture.
• Pregnant or lactating women.
• have poor compliance or other factors that make them unsuitable for participation in this trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RNK08954 Treatment A; 1200mg RNK08954, following an overnight fast of at least 10 hours	Drug: RNK08954; KRAS G12D inhibitor
Experimental: RNK08954 Treatment B; 1200mg RNK08954, administered 30 minutes after the start of a high-fat/high-calorie meal breakfast.	Drug: RNK08954; KRAS G12D inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Ranok Therapeutics (Hangzhou) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): December 31, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 31, 2025
• First Submitted That Met QC Criteria: December 31, 2025
• First Posted (Estimated): January 12, 2026

Study Record Updates

• Last Update Posted (Actual): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: RNK08954-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No