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

Sagimet Biosciences

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: Resmetirom; Drug: Denifanstat

Study type: Interventional

Funder types: Industry

Identifiers

NCT07216313

SB2640-CLIN-013

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Cohort 1

Experimental group

Description:

Effect of resmetirom on pharmacokinetics of denifanstat

Treatment:

Drug: Denifanstat

Drug: Resmetirom

Cohort 2

Experimental group

Description:

Effect of denifanstat on pharmacokinetics of resmetirom

Treatment:

Drug: Denifanstat

Drug: Resmetirom