Drug-Drug Interaction Study of MDR-001 With Rifampin and Itraconazole in Healthy Adult Participants

April 19, 2026 updated by: MindRank AI Ltd

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Adam A. H. Baidoo, MD
  • Phone Number: +8615658610670
  • Email: adam@mindrank.cn

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part A (Rifampin Arm)
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.
Drug: MDR-001
Oral small-molecule GLP-1 receptor agonist ;Investigational drug (not yet approved)
Drug: Rifampin
Strong CYP3A4 inducer; Marketed anti-tuberculosis drug
Experimental: Part B (Itraconazole Arm)
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.
Drug: MDR-001
Oral small-molecule GLP-1 receptor agonist ;Investigational drug (not yet approved)
Drug: Itraconazole
Strong CYP3A4 inhibitor; Marketed antifungal drug

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
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
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.
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
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
Tmax (time to reach Cmax) when administered alone vs. in combination.
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).
t1/2 (terminal elimination half-life) when administered alone vs. in combination.
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).
MRT (mean residence time) when administered alone vs. in combination.
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).
CL/F (apparent clearance) when administered alone vs. in combination.
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).
Vd/F (apparent volume of distribution) when administered alone vs. in combination.
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).
λz (terminal elimination rate constant) when administered alone vs. in combination.
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).
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).
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.
Clinically significant changes from baseline in hematology parameters as measured by complete blood cell count with differential,
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.
Clinically significant changes from baseline in serum chemistry tests
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.
Clinically significant changes from baseline in coagulation tests.
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.
Clinically significant changes from baseline in urinalysis
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.
Clinically significant changes from baseline in thyroid function tests.
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.
Changes from baseline in PR interval
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.
Changes from baseline in QRS duration
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.
Changes from baseline in QT interval
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.
Changes from baseline in QTcF interval.
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.
Changes from baseline in heart rate.
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.
Changes from baseline in systolic and diastolic blood pressure
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.
Changes from baseline in pulse rate.
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.
Changes from baseline in body temperature.
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.
Clinically significant abnormalities in general physical examination.
Screening, Day -1, Day 3, co-administration day (Day 10 or 7), Day 12 or 9, and early termination.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MindRank AI Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xiaojiao Li, MD, The First Hospital of Jilin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 6, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 8, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MDR-001-CN-06

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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