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

NCT07550621 | Not Yet Recruiting Phase 1

• 1 other identifier: MDR-001-CN-06
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers (HV)

Keywords

MDR-001; GLP-1 receptor agonist; Drug-drug interaction (DDI); Rifampin; Itraconazole; CYP3A4 inducer; CYP3A4 inhibitor; Pharmacokinetics (PK); Healthy volunteers

Outcome Measures

Primary Outcomes (3)

• 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).

  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.

  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

  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

  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

  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

  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

  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

  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).

Study Arms (2)

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.

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.

Drug: MDR-001; Drug: Itraconazole

Interventions

MDR-001 DRUG

Oral small-molecule GLP-1 receptor agonist ;Investigational drug (not yet approved)

Part A (Rifampin Arm); Part B (Itraconazole Arm)

Rifampin DRUG

Strong CYP3A4 inducer; Marketed anti-tuberculosis drug

Part A (Rifampin Arm)

Itraconazole DRUG

Strong CYP3A4 inhibitor; Marketed antifungal drug

Part B (Itraconazole Arm)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MindRank AI Ltd: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

MeSH Terms

Interventions

Rifampin; Itraconazole

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Piperazines

Study Officials

• Xiaojiao Li, MD

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guodong Li, PhD

CONTACT

+8618968027256; guodong.li@mindrank.cn

Adam A. H. Baidoo, MD

CONTACT

+8615658610670; adam@mindrank.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 11, 2026
• First Posted: April 24, 2026
• Study Start: May 6, 2026
• Primary Completion: May 31, 2026
• Study Completion: June 8, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

CN (1)