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

A Phase 1, Open-Label Study to Evaluate the Mutual Drug-Drug Interaction Potential Between Denifanstat and Resmetirom in Healthy Adult Participants

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07216313

Enrollment

Registered

2025-10-14

Start date

2025-09-30

Completion date

2025-10-20

Last updated

2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

Interventions

DRUGDenifanstat

Once daily

DRUGResmetirom

Once daily

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026