DelfaGLP-1 Atlas

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Not yet recruitingPhase 1

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

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

Lead sponsor

MindRank AI Ltd

Asset

MDR-001

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

28

estimated

Study population

Healthy volunteers

Key I/E criteria

•BMI 18-28•Healthy volunteers

Primary endpoints

•Cmax of MDR-001•AUC0-t of MDR-001•AUC0-∞ of MDR-001

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07550621
Org study IDMDR-001-CN-06

Timeline

Milestones

Study first posted2026-04-24actual
Last update posted2026-04-24actual
Study start2026-05-06estimated
Primary completion2026-05-31estimated
Study completion2026-06-08estimated

Assets

Investigational agents

MDR-001

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexAll
Healthy volunteersAccepted

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.

Endpoints (24)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
21
Cardiometabolic biomarkers
3

Cardiometabolic biomarkers

3 endpoints
Secondary/protocol endpoint

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.

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

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.

Systolic BP, change

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

LOINC 8480-6

Secondary/protocol endpoint

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.

Heart rate, change

change from baseline, improvement

Safety / tolerability / PK

21 endpoints
Primary/protocol endpoint

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).

Cmax

concentration, descriptive

Primary/protocol endpoint

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).

concentration, descriptive

Primary/protocol endpoint

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).

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

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

descriptive

Secondary/protocol endpoint

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).

Half-life

descriptive

Secondary/protocol endpoint

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).

descriptive

Secondary/protocol endpoint

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).

descriptive

Secondary/protocol endpoint

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).

descriptive

Secondary/protocol endpoint

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).

descriptive

Secondary/protocol endpoint

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).

Treatment-emergent AEs (any)

descriptive, event

componentsTreatment-emergent AEs (any), Serious AEs (any), Nausea, Severe hypoglycemia, Pancreatitis, Thyroid event

Secondary/protocol endpoint

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.

change from baseline, event

Secondary/protocol endpoint

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.

change from baseline, event

Secondary/protocol endpoint

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.

change from baseline, descriptive

Secondary/protocol endpoint

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.

change from baseline, event

Secondary/protocol endpoint

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.

Thyroid event

change from baseline, event

Secondary/protocol endpoint

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.

change from baseline, descriptive

Secondary/protocol endpoint

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.

change from baseline, descriptive

Secondary/protocol endpoint

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.

change from baseline, descriptive

Secondary/protocol endpoint

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.

change from baseline, descriptive

Secondary/protocol endpoint

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.

change from baseline, descriptive

Secondary/protocol endpoint

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.

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.