Healthy volunteers needed to test how food changes drug absorption
NCT ID NCT07334262
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study is for 24 healthy adult men in China. It has two parts: first, to see if eating a high-fat meal changes how the body absorbs the experimental drug RNK08954; second, to track where the drug goes and how it leaves the body. Participants will take the drug once and provide blood and urine samples. There is no direct treatment benefit, but the results help guide future dosing instructions.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shanghai Xuhui Central Hospital
Shanghai, China
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