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Healthy volunteers needed to test how food changes drug absorption

NCT ID NCT07334262

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Shanghai Xuhui Central Hospital

    Shanghai, China

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