Drug-Drug Interaction Study of MDR-001 With Rifampin and Itraconazole
Summary
A Phase I, open-label, fixed-sequence, two-part drug-drug interaction study (NCT07550621) was registered on ClinicalTrials.gov on April 24, 2026, evaluating 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, in healthy Chinese adults. The study is categorized as Phase 1 with Healthy Volunteers as the condition and lists MDR-001, Rifampin, and Itraconazole as interventions.
“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.”
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What changed
A new Phase I clinical trial registration (NCT07550621) was added to ClinicalTrials.gov describing a two-part, open-label, fixed-sequence drug-drug interaction study evaluating MDR-001, an oral GLP-1 receptor agonist, when co-administered with rifampin (Part A) or itraconazole (Part B) in healthy Chinese adult participants.
Affected parties — pharmaceutical sponsors developing oral GLP-1 receptor agonists, clinical research organizations conducting Phase 1 DDI studies, and healthcare providers anticipating MDR-001 use — should note this registration signals active clinical development and potential future regulatory submissions. Drug-drug interaction data with strong and moderate CYP3A4 inducers/inhibitors (rifampin and itraconazole, respectively) will be required for labeling and safety assessments.
Archived snapshot
Apr 24, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Drug-Drug Interaction Study of MDR-001 With Rifampin and Itraconazole in Healthy Adult Participants
Phase 1 NCT07550621 Kind: PHASE1 Apr 24, 2026
Abstract
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)
Interventions: MDR-001, Rifampin, Itraconazole
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