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

NCT07216313 | Completed Phase 1 FDA Drug

• 1 other identifier: SB2640-CLIN-013
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Cohort 1

EXPERIMENTAL

Effect of resmetirom on pharmacokinetics of denifanstat

Drug: Denifanstat; Drug: Resmetirom

Cohort 2

EXPERIMENTAL

Effect of denifanstat on pharmacokinetics of resmetirom

Drug: Denifanstat; Drug: Resmetirom

Interventions

Denifanstat DRUG

Once daily

Cohort 1; Cohort 2

Resmetirom DRUG

Once daily

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not 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.
• 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.

Sponsors & Collaborators

• Sagimet Biosciences Inc.: lead

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Interventions

resmetirom

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2025
• First Posted: October 14, 2025
• Study Start: September 30, 2025
• Primary Completion: October 20, 2025
• Study Completion: October 20, 2025
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)