Healthy Volunteers (HV)Phase 1NCT07550621
Drug-Drug Interaction Study of MDR-001 With Rifampin and Itraconazole in Healthy Adult Participants
A Phase 1 study testing MDR-001, Rifampin and Itraconazole in people with Healthy Volunteers (HV), run by MindRank AI Ltd at 1 site in China.
Trial summary
A Phase I, open-label, fixed-sequence, two-part drug-drug interaction study in healthy Chinese adults to evaluate the effect of multiple-dose rifampin (Part A) or itraconazole (Part B) on the single-dose pharmacokinetics of MDR-001, an oral GLP-1 receptor agonist. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers (HV)
- What is being tested?
- MDR-001, Rifampin and Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2026to 8 Jun 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
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
The First Hospital of Jilin University
Changchun, Jilin, 130021
Xiaojiao Li, MD, +8613514314089, xingxingsuo12345@126.com
About this study
Official title: A Phase 1 Study to Evaluate the Effect of Rifampin on the Pharmacokinetics of MDR-001 and the Effect of Itraconazole on the Pharmacokinetics of MDR-001 in Healthy Adult Study Participants
A Phase I, open-label, fixed-sequence, two-part drug-drug interaction study in healthy Chinese adults to evaluate the effect of multiple-dose rifampin (Part A) or itraconazole (Part B) on the single-dose pharmacokinetics of MDR-001, an oral GLP-1 receptor agonist.
Read the detailed description
This phase 1, single-center, open-label, fixed-sequence drug-drug interaction study will evaluate the effect of multiple-dose rifampicin (a strong CYP3A4 inducer) and multiple-dose itraconazole (a strong CYP3A4 inhibitor) on the single-dose pharmacokinetics of MDR-001, an oral small-molecule GLP-1 receptor agonist being developed for weight management. The study plans to enroll 28 healthy Chinese adults (18-55 years, BMI 18-28 kg/m²), with 12 participants in Part A (rifampicin) and 16 in Part B (itraconazole). The primary outcomes are the effects of rifampicin and itraconazole on Cmax, AUC0-t, and AUC0-∞ of MDR-001. Secondary outcomes include safety and tolerability (adverse events, vital signs, ECG, laboratory tests) and comparison of other pharmacokinetic parameters (Tmax, t1/2, MRT, CL/F, Vd/F, λz) between MDR-001 alone and combined with the interacting drugs.
- Conditions
- Healthy Volunteers (HV)
- Being tested
- MDR-001, Rifampin, Itraconazole
- Keywords
- MDR-001, GLP-1 receptor agonist, Drug-drug interaction (DDI), Rifampin, Itraconazole, CYP3A4 inducer, CYP3A4 inhibitor, Pharmacokinetics (PK), Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDR-001Drug
Oral small-molecule GLP-1 receptor agonist ;Investigational drug (not yet approved)
RifampinDrug
Strong CYP3A4 inducer; Marketed anti-tuberculosis drug
ItraconazoleDrug
Strong CYP3A4 inhibitor; Marketed antifungal drug
| Study group | Role | What they receive |
|---|---|---|
| Part A (Rifampin Arm) | Experimental | Participants receive a single oral dose of MDR-001 alone on Day 1. then rifampin from Day 3 to Day 11, with a second single dose of MDR-001 co-administered on Day 10. Receives: Drug: MDR-001; Drug: Rifampin |
| Part B (Itraconazole Arm) | Experimental | Participants receive a single oral dose of MDR-001alone on Day 1. , then receive itraconazole once daily from Day 3 to Day 8, with a second single dose of MDR-001 co-administered on Day 7. Receives: Drug: MDR-001; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of MDR-001
Maximum observed plasma concentration of MDR-001 after single-dose administration alone and in combination with rifampin (Part A) or itraconazole (Part B).
Measured: Baseline (Day 1 pre-dose) and up to 48 hours post-dose on Day 1 and on co-administration (Day 10 for Part A, Day 7 for Part B).
AUC0-t of MDR-001
Area under the plasma concentration-time curve from time zero to the last measurable concentration after single-dose administration alone and in combination.
Measured: Baseline (Day 1 pre-dose) and up to 48 hours post-dose on Day 1 and on co-administration (Day 10 for Part A, Day 7 for Part B).
AUC0-∞ of MDR-001
Area under the plasma concentration-time curve from time zero extrapolated to infinity after single-dose administration alone and in combinatio
Measured: Baseline (Day 1 pre-dose) and up to 48 hours post-dose on Day 1 and on co-administration (Day 10 for Part A, Day 7 for Part B).
Secondary outcomes (21)
Other Pharmacokinetic Parameters of MDR-001
Tmax (time to reach Cmax) when administered alone vs. in combination.
Measured: Baseline (Day 1 pre-dose) and up to 48 hours post-dose on Day 1 and on co-administration (Day 10 for Part A, Day 7 for Part B).
Other Pharmacokinetic Parameters of MDR-001
t1/2 (terminal elimination half-life) when administered alone vs. in combination.
Measured: Baseline (Day 1 pre-dose) and up to 48 hours post-dose on Day 1 and on co-administration (Day 10 for Part A, Day 7 for Part B).
Other Pharmacokinetic Parameters of MDR-001
MRT (mean residence time) when administered alone vs. in combination.
Measured: Baseline (Day 1 pre-dose) and up to 48 hours post-dose on Day 1 and on co-administration (Day 10 for Part A, Day 7 for Part B).
Other Pharmacokinetic Parameters of MDR-001
CL/F (apparent clearance) when administered alone vs. in combination.
Measured: Baseline (Day 1 pre-dose) and up to 48 hours post-dose on Day 1 and on co-administration (Day 10 for Part A, Day 7 for Part B).
Other Pharmacokinetic Parameters of MDR-001
Vd/F (apparent volume of distribution) when administered alone vs. in combination.
Measured: Baseline (Day 1 pre-dose) and up to 48 hours post-dose on Day 1 and on co-administration (Day 10 for Part A, Day 7 for Part B).
Other Pharmacokinetic Parameters of MDR-001
λz (terminal elimination rate constant) when administered alone vs. in combination.
Measured: Baseline (Day 1 pre-dose) and up to 48 hours post-dose on Day 1 and on co-administration (Day 10 for Part A, Day 7 for Part B).
Safety and Tolerability - Adverse Events
Incidence, severity, and causality of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESI: grade ≥2 gastrointestinal events, grade 3 hypoglycemia, acute pancreatitis, thyroid C-cell tumors).
Measured: From first dose of study drug (Day 1) through follow-up phone call (Day 19 ±2 for Part A, Day 16 ±2 for Part B).
Safety and Tolerability - Clinical Laboratory Tests
Clinically significant changes from baseline in hematology parameters as measured by complete blood cell count with differential,
Measured: Screening, Day -1, Day 3, Day 6 (Part A only), Day 10 or 7 (co-administration day), and Day 12 or 9 (discharge) or early termination.
Safety and Tolerability - Clinical Laboratory Tests
Clinically significant changes from baseline in serum chemistry tests
Measured: Screening, Day -1, Day 3, Day 6 (Part A only), Day 10 or 7 (co-administration day), and Day 12 or 9 (discharge) or early termination.
Safety and Tolerability - Clinical Laboratory Tests
Clinically significant changes from baseline in coagulation tests.
Measured: Screening, Day -1, Day 3, Day 6 (Part A only), Day 10 or 7 (co-administration day), and Day 12 or 9 (discharge) or early termination.
Safety and Tolerability - Clinical Laboratory Tests
Clinically significant changes from baseline in urinalysis
Measured: Screening, Day -1, Day 3, Day 6 (Part A only), Day 10 or 7 (co-administration day), and Day 12 or 9 (discharge) or early termination.
Safety and Tolerability - Clinical Laboratory Tests
Clinically significant changes from baseline in thyroid function tests.
Measured: Screening, Day -1, Day 3, Day 6 (Part A only), Day 10 or 7 (co-administration day), and Day 12 or 9 (discharge) or early termination.
Safety and Tolerability - 12 Lead ECG
Changes from baseline in PR interval
Measured: Screening, Day -1, Day 1 (pre-dose and 2h post-dose), Day 3, Day 6 (Part A), Day 10 or 7 (pre-dose and 2h post-dose), Day 12 or 9, and early termination.
Safety and Tolerability - 12-Lead ECG
Changes from baseline in QRS duration
Measured: Screening, Day -1, Day 1 (pre-dose and 2h post-dose), Day 3, Day 6 (Part A), Day 10/7 (pre-dose and 2h post-dose), Day 12/9, and early termination.
Safety and Tolerability - 12 Lead ECG
Changes from baseline in QT interval
Measured: Screening, Day -1, Day 1 (pre-dose and 2h post-dose), Day 3, Day 6 (Part A), Day 10 or 7 (pre-dose and 2h post-dose), Day 12 or 9, and early termination.
Safety and Tolerability - 12 Lead ECG
Changes from baseline in QTcF interval.
Measured: Screening, Day -1, Day 1 (pre-dose and 2h post-dose), Day 3, Day 6 (Part A), Day 10 or 7 (pre-dose and 2h post-dose), Day 12 or 9, and early termination.
Safety and Tolerability - 12 Lead ECG
Changes from baseline in heart rate.
Measured: Screening, Day -1, Day 1 (pre-dose and 2h post-dose), Day 3, Day 6 (Part A), Day 10 or 7 (pre-dose and 2h post-dose), Day 12 or 9, and early termination.
Safety and Tolerability - Vital Signs
Changes from baseline in systolic and diastolic blood pressure
Measured: Screening, Day -1, Day 1 and co-administration day (pre-dose, 2h and 6h post-dose), Day 2, Day 3-9 or 11 (daily), Day 12 or 9, and early termination.
Safety and Tolerability - Vital Signs
Changes from baseline in pulse rate.
Measured: Screening, Day -1, Day 1 and co-administration day (pre-dose, 2h and 6h post-dose), Day 2, Day 3-9 or 11 (daily), Day 12 or 9, and early termination.
Safety and Tolerability - Vital Signs
Changes from baseline in body temperature.
Measured: Screening, Day -1, Day 1 and co-administration day (pre-dose, 2h and 6h post-dose), Day 2, Day 3-9 or 11 (daily), Day 12 or 9, and early termination.
Safety and Tolerability - Physical Examination
Clinically significant abnormalities in general physical examination.
Measured: Screening, Day -1, Day 3, co-administration day (Day 10 or 7), Day 12 or 9, and early termination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start6 May 2026 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion8 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers (HV)Studies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Fixed-sequence crossover design where each participant serves as their own control. The study consists of two independent, non-randomized, open-label parts: Part A and B. The design allows within-participant comparison of pharmacokinetic parameters (alone vs. combination) for each part independently.
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MindRank AI Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaojiao Li, MD, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550621
- Sponsor's protocol ID
- MDR-001-CN-06
- Status last verified
- Apr 2026
- First submitted
- 11 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Effect of Rifampin on the Pharmacokinetics of MDR-001 and the Effect of Itraconazole on the Pharmacokinetics of MDR-001 in Healthy Adult Study Participants
- ClinicalTrials.gov ID
- NCT07550621
- Acronym / sponsor ID
- MDR-001-CN-06
- Conditions
- Healthy Volunteers (HV)
- Keywords
- MDR-001, GLP-1 receptor agonist, Drug-drug interaction (DDI), Rifampin, Itraconazole, CYP3A4 inducer, CYP3A4 inhibitor, Pharmacokinetics (PK)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- MindRank AI LtdIndustry (pharma, biotech, devices)
- Study start
- 6 May 2026 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 8 Jun 2026 (estimated)
- First posted
- 24 Apr 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.
A Phase I, open-label, fixed-sequence, two-part drug-drug interaction study in healthy Chinese adults to evaluate the effect of multiple-dose rifampin (Part A) or itraconazole (Part B) on the single-dose pharmacokinetics of MDR-001, an oral GLP-1 receptor agonist.
Detailed description
This phase 1, single-center, open-label, fixed-sequence drug-drug interaction study will evaluate the effect of multiple-dose rifampicin (a strong CYP3A4 inducer) and multiple-dose itraconazole (a strong CYP3A4 inhibitor) on the single-dose pharmacokinetics of MDR-001, an oral small-molecule GLP-1 receptor agonist being developed for weight management. The study plans to enroll 28 healthy Chinese adults (18-55 years, BMI 18-28 kg/m²), with 12 participants in Part A (rifampicin) and 16 in Part B (itraconazole). The primary outcomes are the effects of rifampicin and itraconazole on Cmax, AUC0-t, and AUC0-∞ of MDR-001. Secondary outcomes include safety and tolerability (adverse events, vital signs, ECG, laboratory tests) and comparison of other pharmacokinetic parameters (Tmax, t1/2, MRT, CL/F, Vd/F, λz) between MDR-001 alone and combined with the interacting drugs.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Fixed-sequence crossover design where each participant serves as their own control. The study consists of two independent, non-randomized, open-label parts: Part A and B. The design allows within-participant comparison of pharmacokinetic parameters (alone vs. combination) for each part independently.
| Arm | Type | Receives |
|---|---|---|
| Part A (Rifampin Arm) | Experimental | Drug: MDR-001, Drug: RifampinParticipants receive a single oral dose of MDR-001 alone on Day 1. then rifampin from Day 3 to Day 11, with a second single dose of MDR-001 co-administered on Day 10. |
| Part B (Itraconazole Arm) | Experimental | Drug: MDR-001, Drug: ItraconazoleParticipants receive a single oral dose of MDR-001alone on Day 1. , then receive itraconazole once daily from Day 3 to Day 8, with a second single dose of MDR-001 co-administered on Day 7. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (25 listed)
- 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.
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 |
|---|---|---|
| MDR-001Oral small-molecule GLP-1 receptor agonist ;Investigational drug (not yet approved) | Drug | Part A (Rifampin Arm), Part B (Itraconazole Arm) |
| RifampinStrong CYP3A4 inducer; Marketed anti-tuberculosis drug | Drug | Part A (Rifampin Arm) |
| ItraconazoleStrong CYP3A4 inhibitor; Marketed antifungal drug | Drug | Part B (Itraconazole Arm) |
Primary outcome
Cmax of MDR-001
Time frame: Baseline (Day 1 pre-dose) and up to 48 hours post-dose on Day 1 and on co-administration (Day 10 for Part A, Day 7 for Part B).
Maximum observed plasma concentration of MDR-001 after single-dose administration alone and in combination with rifampin (Part A) or itraconazole (Part B).
AUC0-t of MDR-001
Time frame: Baseline (Day 1 pre-dose) and up to 48 hours post-dose on Day 1 and on co-administration (Day 10 for Part A, Day 7 for Part B).
Area under the plasma concentration-time curve from time zero to the last measurable concentration after single-dose administration alone and in combination.
AUC0-∞ of MDR-001
Time frame: Baseline (Day 1 pre-dose) and up to 48 hours post-dose on Day 1 and on co-administration (Day 10 for Part A, Day 7 for Part B).
Area under the plasma concentration-time curve from time zero extrapolated to infinity after single-dose administration alone and in combinatio
21 secondary outcomes
Other Pharmacokinetic Parameters of MDR-001
Time frame: Baseline (Day 1 pre-dose) and up to 48 hours post-dose on Day 1 and on co-administration (Day 10 for Part A, Day 7 for Part B).
Other Pharmacokinetic Parameters of MDR-001
Time frame: Baseline (Day 1 pre-dose) and up to 48 hours post-dose on Day 1 and on co-administration (Day 10 for Part A, Day 7 for Part B).
Other Pharmacokinetic Parameters of MDR-001
Time frame: Baseline (Day 1 pre-dose) and up to 48 hours post-dose on Day 1 and on co-administration (Day 10 for Part A, Day 7 for Part B).
Other Pharmacokinetic Parameters of MDR-001
Time frame: Baseline (Day 1 pre-dose) and up to 48 hours post-dose on Day 1 and on co-administration (Day 10 for Part A, Day 7 for Part B).
Other Pharmacokinetic Parameters of MDR-001
Time frame: Baseline (Day 1 pre-dose) and up to 48 hours post-dose on Day 1 and on co-administration (Day 10 for Part A, Day 7 for Part B).
Other Pharmacokinetic Parameters of MDR-001
Time frame: Baseline (Day 1 pre-dose) and up to 48 hours post-dose on Day 1 and on co-administration (Day 10 for Part A, Day 7 for Part B).
Safety and Tolerability - Adverse Events
Time frame: From first dose of study drug (Day 1) through follow-up phone call (Day 19 ±2 for Part A, Day 16 ±2 for Part B).
Safety and Tolerability - Clinical Laboratory Tests
Time frame: Screening, Day -1, Day 3, Day 6 (Part A only), Day 10 or 7 (co-administration day), and Day 12 or 9 (discharge) or early termination.
Safety and Tolerability - Clinical Laboratory Tests
Time frame: Screening, Day -1, Day 3, Day 6 (Part A only), Day 10 or 7 (co-administration day), and Day 12 or 9 (discharge) or early termination.
Safety and Tolerability - Clinical Laboratory Tests
Time frame: Screening, Day -1, Day 3, Day 6 (Part A only), Day 10 or 7 (co-administration day), and Day 12 or 9 (discharge) or early termination.
Safety and Tolerability - Clinical Laboratory Tests
Time frame: Screening, Day -1, Day 3, Day 6 (Part A only), Day 10 or 7 (co-administration day), and Day 12 or 9 (discharge) or early termination.
Safety and Tolerability - Clinical Laboratory Tests
Time frame: Screening, Day -1, Day 3, Day 6 (Part A only), Day 10 or 7 (co-administration day), and Day 12 or 9 (discharge) or early termination.
Safety and Tolerability - 12 Lead ECG
Time frame: Screening, Day -1, Day 1 (pre-dose and 2h post-dose), Day 3, Day 6 (Part A), Day 10 or 7 (pre-dose and 2h post-dose), Day 12 or 9, and early termination.
Safety and Tolerability - 12-Lead ECG
Time frame: Screening, Day -1, Day 1 (pre-dose and 2h post-dose), Day 3, Day 6 (Part A), Day 10/7 (pre-dose and 2h post-dose), Day 12/9, and early termination.
Safety and Tolerability - 12 Lead ECG
Time frame: Screening, Day -1, Day 1 (pre-dose and 2h post-dose), Day 3, Day 6 (Part A), Day 10 or 7 (pre-dose and 2h post-dose), Day 12 or 9, and early termination.
Safety and Tolerability - 12 Lead ECG
Time frame: Screening, Day -1, Day 1 (pre-dose and 2h post-dose), Day 3, Day 6 (Part A), Day 10 or 7 (pre-dose and 2h post-dose), Day 12 or 9, and early termination.
Safety and Tolerability - 12 Lead ECG
Time frame: Screening, Day -1, Day 1 (pre-dose and 2h post-dose), Day 3, Day 6 (Part A), Day 10 or 7 (pre-dose and 2h post-dose), Day 12 or 9, and early termination.
Safety and Tolerability - Vital Signs
Time frame: Screening, Day -1, Day 1 and co-administration day (pre-dose, 2h and 6h post-dose), Day 2, Day 3-9 or 11 (daily), Day 12 or 9, and early termination.
Safety and Tolerability - Vital Signs
Time frame: Screening, Day -1, Day 1 and co-administration day (pre-dose, 2h and 6h post-dose), Day 2, Day 3-9 or 11 (daily), Day 12 or 9, and early termination.
Safety and Tolerability - Vital Signs
Time frame: Screening, Day -1, Day 1 and co-administration day (pre-dose, 2h and 6h post-dose), Day 2, Day 3-9 or 11 (daily), Day 12 or 9, and early termination.
Safety and Tolerability - Physical Examination
Time frame: Screening, Day -1, Day 3, co-administration day (Day 10 or 7), Day 12 or 9, and early termination.
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 24 Apr 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.
Xiaojiao Li, MD principal investigator
The First Hospital of Jilin University
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 MDR-001, Rifampin and Itraconazole in people with Healthy Volunteers (HV), run by MindRank AI 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 6 inclusion and 25 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 24 Apr 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 Guodong Li, PhD (+8618968027256, guodong.li@mindrank.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of MDR-001 (time frame: Baseline (Day 1 pre-dose) and up to 48 hours post-dose on Day 1 and on co-administration (Day 10 for Part A, Day 7 for Part B).). The study lists 3 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 24 Apr 2026.