A Drug-Drug Interaction Study of Denifanstat and Resmetirom in Healthy Adult Participants (NCT07216313) | Clinical Trial Compass
CompletedPhase 1
A Drug-Drug Interaction Study of Denifanstat and Resmetirom in Healthy Adult Participants
United States40 participantsStarted 2025-09-30
Plain-language summary
This is an open-label, 2-cohort study to evaluate the mutual DDI potential between denifanstat and resmetirom in healthy adult participants.
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Additional inclusion and exclusion criteria may apply.
Inclusion Criteria:
* 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 Criteria:
* 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 t…
What they're measuring
1
Area under the concentration-time curve during a dosing interval (tau) at steady state (AUC0-tau)
Timeframe: 7 days
2
Maximum observed concentration at steady-state (Cmax,ss)