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

NCT07334262 | Not Yet Recruiting Phase 1

• 1 other identifier: RNK08954-03
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Food Effect; Mass Balance

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Incidence,frequency and severity of adverse events (AEs）of RNK08954 as assessed by CTCAE 5.0

  30 days

• Electrocardiogram (ECG) parameters: HR, PR, QRS, QT, and QTc

  30 days

• Systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHG)

  30 days

Study Arms (2)

RNK08954 Treatment A

EXPERIMENTAL

1200mg RNK08954, following an overnight fast of at least 10 hours

Drug: RNK08954

RNK08954 Treatment B

EXPERIMENTAL

1200mg RNK08954, administered 30 minutes after the start of a high-fat/high-calorie meal breakfast.

Drug: RNK08954

Interventions

RNK08954 DRUG

KRAS G12D inhibitor

RNK08954 Treatment A; RNK08954 Treatment B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Shanghai Xuhui Central Hospital

Shanghai, China

Location

Central Study Contacts

Xin Wu

CONTACT

86-0571-86630936; xinwu@ranoktherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2025
• First Posted: January 12, 2026
• Study Start: December 31, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

CN (1)