Food EffectPhase 1NCT07334262
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 Phase 1 study testing RNK08954 in people with Food Effect and Mass Balance, run by Ranok Therapeutics (Hangzhou) Co., Ltd. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Effect, Mass Balance
- What is being tested?
- RNK08954
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2025to 1 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Xuhui Central Hospital
Shanghai
YanMei Liu, 86-13564045062, ymliu@shxh-centerlab.com
About this study
Official title: 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
- Conditions
- Food Effect, Mass Balance
- Being tested
- RNK08954
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RNK08954Drug
KRAS G12D inhibitor
| Study group | Role | What they receive |
|---|---|---|
| RNK08954 Treatment A | Experimental | 1200mg RNK08954, following an overnight fast of at least 10 hours Receives: Drug: RNK08954 |
| RNK08954 Treatment B | Experimental | 1200mg RNK08954, administered 30 minutes after the start of a high-fat/high-calorie meal breakfast. Receives: Drug: RNK08954 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 30 days
Secondary outcomes (3)
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.
Measured: 30 days
Electrocardiogram (ECG) parameters: HR, PR, QRS, QT, and QTc
Safety and tolerability measures will be recorded at the indicated timepoints
Measured: 30 days
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHG)
Safety and tolerability measures will be recorded at the indicated timepoints
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start31 Dec 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food EffectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ranok Therapeutics (Hangzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334262
- Sponsor's protocol ID
- RNK08954-03
- Status last verified
- Jan 2026
- First submitted
- 31 Dec 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07334262
- Acronym / sponsor ID
- RNK08954-03
- Conditions
- Food Effect, Mass Balance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Ranok Therapeutics (Hangzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RNK08954 Treatment A | Experimental | Drug: RNK089541200mg RNK08954, following an overnight fast of at least 10 hours |
| RNK08954 Treatment B | Experimental | Drug: RNK089541200mg RNK08954, administered 30 minutes after the start of a high-fat/high-calorie meal breakfast. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RNK08954KRAS G12D inhibitor | Drug | RNK08954 Treatment A, RNK08954 Treatment B |
Primary outcome
Plasma Pharmacokinetics (PK) of a single dose of RNK08954 after a standardized high-fat/high-calorie meal and after fasting: Tmax
Time frame: 30 days
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
Time frame: 30 days
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
Time frame: 30 days
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
Time frame: 30 days
Area under plasma Concentration (AUC) from zero to infinity
Plasma Pharmacokinetics (PK) of a single dose of RNK08954 after a standardized high-fat/high-calorie meal and after fasting: AUC0-last
Time frame: 30 days
Area Under the concentration-time Curve from time zero to the time of the last
3 secondary outcomes
Incidence,frequency and severity of adverse events (AEs）of RNK08954 as assessed by CTCAE 5.0
Time frame: 30 days
Electrocardiogram (ECG) parameters: HR, PR, QRS, QT, and QTc
Time frame: 30 days
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHG)
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RNK08954 in people with Food Effect and Mass Balance, run by Ranok Therapeutics (Hangzhou) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xin Wu (86-0571-86630936, xinwu@ranoktherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Pharmacokinetics (PK) of a single dose of RNK08954 after a standardized high-fat/high-calorie meal and after fasting: Tmax (time frame: 30 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.