Status:
ACTIVE_NOT_RECRUITING
A Drug-Drug Interaction Study of Denifanstat and Resmetirom in Healthy Adult Participants
Lead Sponsor:
Sagimet Biosciences Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is an open-label, 2-cohort study to evaluate the mutual DDI potential between denifanstat and resmetirom in healthy adult participants.
Eligibility Criteria
Inclusion
- Additional inclusion and exclusion criteria may apply.
- Seated blood pressure is ≥ 90/40 mmHg and ≤ 140/90 mmHg at the screening visit.
- Seated pulse rate is ≥ 40 bpm and ≤ 99 bpm at the screening visit.
- QTcF interval is ≤ 460 msec (males) and ≤ 470 msec (females) and has ECG findings considered normal or not clinically significant by the PI or designee at the screening visit.
- Liver function test including ALT, AST, ALP and total bilirubin ≤ upper limit of normal at the screening visit.
- Estimated CrCL ≥ 80 mL/min at the screening visit.
Exclusion
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder.
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (cholecystectomy will not be allowed; uncomplicated appendectomy and hernia repair will be allowed).
- Presence of any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines.
- History or presence of hepatobiliary or thyroid-related disease.
- Significant change (approximately 10% increase or decrease) in weight within 3 months prior to first dosing in the opinion of the PI or designee.
- History of alcoholism or drug/chemical abuse within 2 years prior to check-in.
- Positive results for HIV, HBsAg, or HCV at the screening visit.
- Poor peripheral venous access.
Key Trial Info
Start Date :
September 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07216313
Start Date
September 30 2025
End Date
October 20 2025
Last Update
October 16 2025
Active Locations (1)
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1
Celerion
Tempe, Arizona, United States, 85283