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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Contact
Study Contact
- Name: Xin Wu
- Phone Number: 86-0571-86630936
- Email: xinwu@ranoktherapeutics.com
Study Locations
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-
-
Shanghai, China
- Shanghai Xuhui Central Hospital
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Contact:
- YanMei Liu
- Phone Number: 86-13564045062
- Email: ymliu@shxh-centerlab.com
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: RNK08954 Treatment A
1200mg RNK08954, following an overnight fast of at least 10 hours
|
KRAS G12D inhibitor
|
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Experimental: RNK08954 Treatment B
1200mg RNK08954, administered 30 minutes after the start of a high-fat/high-calorie meal breakfast.
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KRAS G12D inhibitor
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What is the study measuring?
Primary Outcome Measures
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 Frame: 30 days
|
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
Time Frame: 30 days
|
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
Time Frame: 30 days
|
Cmax for RNK08954 administered with and without food.
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30 days
|
|
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
|
30 days
|
|
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
|
30 days
|
Secondary Outcome Measures
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
Time Frame: 30 days
|
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
Time Frame: 30 days
|
Safety and tolerability measures will be recorded at the indicated timepoints
|
30 days
|
|
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHG)
Time Frame: 30 days
|
Safety and tolerability measures will be recorded at the indicated timepoints
|
30 days
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimated)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- RNK08954-03
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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