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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2025-10-20

Brief Summary

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

Effect of resmetirom on pharmacokinetics of denifanstat

Group Type EXPERIMENTAL

Denifanstat

Intervention Type DRUG

Once daily

Resmetirom

Intervention Type DRUG

Once daily

Cohort 2

Effect of denifanstat on pharmacokinetics of resmetirom

Group Type EXPERIMENTAL

Denifanstat

Intervention Type DRUG

Once daily

Resmetirom

Intervention Type DRUG

Once daily

Interventions

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Denifanstat

Once daily

Intervention Type DRUG

Resmetirom

Once daily

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes