Healthy volunteers needed to test new drug interactions
NCT ID NCT07550621
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how two common drugs, rifampin and itraconazole, change the levels of MDR-001 in the body. It involves 28 healthy Chinese adults who will take MDR-001 alone and then with one of the other drugs. The goal is to gather safety and drug-level data, not to treat any disease.
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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 28 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 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 55 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: * Voluntary participation and signed informed consent before any study procedures, with full understanding of the study content, procedures, and potential adverse reactions. * Healthy Chinese adult males or females aged 18 to 55 years (inclusive). * Body weight ≥50 kg for males and ≥45 kg for females, and body mass index (BMI) between 18 and 28 kg/m² (inclusive). * Judged by the investigator to be in good health, with medical history, laboratory tests, physical examination, vital signs, and ECG results being normal or abnormal without clinical significance. * Participants and their partners must have no pregnancy plan and agree to use effective non-drug contraceptive measures (e.g., condoms, non-medicated intrauterine devices) from 2 weeks before screening until 6 months after the end of the study, unless permanent sterilization has been performed (e.g., bilateral tubal ligation, vasectomy). * Willing to comply with the visit schedule, study treatment, laboratory tests, and other study-related procedures and requirements as specified in the protocol. Exclusion Criteria: * Average daily smoking \>5 cigarettes within 3 months before dosing. * History of headaches (e.g., migraine, tension-type headache). * Allergic constitution (multiple drug or food allergies) or intolerance/allergy to the active ingredient or excipients of the study drugs. * History of alcohol abuse (≥14 units of alcohol per week; 1 unit = 285 mL beer, 25 mL spirits, or 100 mL wine). * History of drug abuse or use of illicit drugs within 5 years before dosing. * Blood donation or significant blood loss (≥400 mL) within 3 months before dosing, or planned blood donation during the study. * Any disease that increases bleeding risk, such as acute gastritis or gastric/duodenal ulcer. * Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2), or genetic conditions predisposing to MTC. * History of pancreatitis or symptomatic gallbladder disease. * Serum calcitonin \> upper limit of normal (ULN) at screening. * Dysphagia, or gastrointestinal disorders affecting absorption (e.g., diarrhea, vomiting, inflammatory bowel disease, active ulcer), or history of gastrointestinal surgery leading to malabsorption, or long-term use of drugs affecting gastrointestinal motility (e.g., bariatric surgery such as gastric banding). * Special dietary requirements and unable to accept standardized meals. * Surgery within 3 months before dosing, or planned surgery during the study, or surgery that affects drug absorption, distribution, metabolism, or excretion. * Received live attenuated vaccine within 1 month before dosing, or planned vaccination during the study. * Use of any prescription drug, over-the-counter drug, vitamin product, or herbal medicine within 14 days before dosing. * Significant changes in diet or exercise habits within 3 months before dosing. * Use of CYP3A4 inhibitors, CYP3A4 inducers, or P-gp inhibitors within 14 days before the first dose, or planned use during the study. * Participation in another clinical trial or receipt of an investigational drug within 3 months before dosing (unless the participant withdrew before treatment/randomization). * ECG abnormalities with clinical significance at screening; QTcF \>450 msec (males) or \>470 msec (females) by Fridericia's correction. * Pregnant, lactating, or positive pregnancy test in females of childbearing potential. * Clinically significant laboratory abnormalities, or clinically significant diseases within 12 months before dosing (respiratory, circulatory, digestive, endocrine, rheumatic/immune, nervous, hematologic, or psychiatric disorders) that make the participant unsuitable for the study. * Positive screening for hepatitis B surface antigen, hepatitis C antibody/core antigen, HIV antibody, or syphilis antibody. * Acute illness or concomitant medication between screening and first dose. * Positive alcohol breath test or urine drug screen. * Any other condition judged by the investigator as unsuitable for participation.
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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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The First Hospital of Jilin University
Changchun, Jilin, 130021, China
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