A Drug-Drug Interaction Study of Denifanstat and Resmetirom in Healthy Adult Participants
Completed · Phase 1
Conditions studied: Healthy
In brief
This is an open-label, 2-cohort study to evaluate the mutual DDI potential between denifanstat and resmetirom in healthy adult participants.
Key facts
- Study ID
- NCT07216313
- Run by
- Sagimet Biosciences Inc.
- People needed
- 40
- Starts
- 2025-09-30
- Expected to finish
- 2025-10-20
- Last updated by the study team
- 2026-01-23
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Celerion — Tempe, Arizona, United States
Full record on ClinicalTrials.gov
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