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.
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.
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).
Crossover
MDR-001
DrugOral small-molecule GLP-1 receptor agonist ;Investigational drug (not yet approved)
Rifampin
DrugStrong CYP3A4 inducer; Marketed anti-tuberculosis drug
Itraconazole
DrugStrong CYP3A4 inhibitor; Marketed antifungal drug
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).
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.
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
Other Pharmacokinetic Parameters of MDR-001
Tmax (time to reach Cmax) when administered alone vs. in combination.
Other Pharmacokinetic Parameters of MDR-001
t1/2 (terminal elimination half-life) when administered alone vs. in combination.
Other Pharmacokinetic Parameters of MDR-001
MRT (mean residence time) when administered alone vs. in combination.
Other Pharmacokinetic Parameters of MDR-001
CL/F (apparent clearance) when administered alone vs. in combination.
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