A Drug-Drug Interaction Study of Denifanstat and Resmetirom in Healthy Adult Participants

Not Applicable

Active, not recruiting

• Conditions: Healthy
• Interventions: Drug: Denifanstat; Drug: Resmetirom

• Registration Number: NCT07216313
• Lead Sponsor: Sagimet Biosciences Inc.

Brief Summary

This is an open-label, 2-cohort study to evaluate the mutual DDI potential between denifanstat and resmetirom in healthy adult participants.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-09-30
• Status Verified: 2025-10
• Study First Submitted: 2025-10-08
• Study First Submitted QC: 2025-10-10
• Study First Posted: 2025-10-14
• Last Update Submitted: 2025-10-14
• Last Update Posted: 2025-10-16
• Primary Completion: 2025-10-20
• Study Completion: 2025-10-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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 to check-in.
• Positive results for HIV, HBsAg, or HCV at the screening visit.
• Poor peripheral venous access.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cohort 1	Denifanstat	Effect of resmetirom on pharmacokinetics of denifanstat
Cohort 1	Resmetirom	Effect of resmetirom on pharmacokinetics of denifanstat
Cohort 2	Denifanstat	Effect of denifanstat on pharmacokinetics of resmetirom
Cohort 2	Resmetirom	Effect of denifanstat on pharmacokinetics of resmetirom

Primary Outcome Measures

Name	Time	Method
Area under the concentration-time curve during a dosing interval (tau) at steady state (AUC0-tau)	7 days
Maximum observed concentration at steady-state (Cmax,ss)	7 days

Trial Locations

Locations (1)

Celerion; 🇺🇸 Tempe, Arizona, United States